HEAD REST

Description of Event or Problem

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR ACCESSORIES 113053B0 - HEAD REST WITH DOUBLE ARTICULATION USED WITH 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THAT THE HEADREST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY, CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEADREST DETACHMENT CAUSING THE HYPEREXTENSION IN THE PATIENT¿S NECK, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR ACCESSORIES 113053B0 - HEAD REST WITH DOUBLE ARTICULATION USED WITH 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THAT THE HEADREST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY, CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEADREST DETACHMENT CAUSING THE HYPEREXTENSION IN THE PATIENT¿S NECK, WAS TO REOCCUR. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR INCIDENT OCCURRED. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WERE ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS NO RELEVANT MALFUNCTION WITH THE DEVICE WAS REPORTED, IT HAS BEEN ASSESSED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. THE INVOLVED DEVICES WERE EVALUATED BY A GETINGE TECHNICIAN. THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE OVERRIDE PANEL. NO ISSUES WITH SECURING THE HEADREST WERE FOUND. THE LOCKS ANCHORED AND SECURED EASILY. THE UP AND DOWN MOVEMENT OF THE HEAD WAS CHECKED. IT WAS CONFIRMED THAT THE LOCK WORKS CORRECTLY AND DOES NOT SHOW SIGNS OF WEAR. THE DEVICE DID NOT PRESENT ANY DEFORMITY IN ITS MATERIAL. THE GETINGE TECHNICIAN REPORTED THAT THE USER HAD INCORRECTLY POSITIONED THE HEADREST OF THE OPERATING TABLE. THE INSTRUCTION FOR USE FOR THE AFFECTED MOBILE TABLE (GA 1131.12 REV. 6, PAGE 65) PROVIDES INFORMATION ON THE CORRECT SETUP FOR ATTACHING THE 113053B0 - HEAD REST WITH DOUBLE ARTICULATION TO THE 113112B0 - BETASTAR MOBILE OPERATING TABLE. THE CORRECT MOUNTING AND ADJUSTMENTS OF THE HEADREST ARE ALSO DESCRIBED IN THE HEAD REST¿S USER MANUAL (IFU 1130.53 REV. 9, PAGE 15-17). THE USER IS WARNED THAT PRODUCTS / ACCESSORIES THAT ARE NOT ATTACHED PROPERLY MAY LOOSEN AND CAUSE INJURIES (IFU 1130.53 REV. 9, PAGE 12). THE USER IS ADVISED TO ENSURE THAT PRODUCTS / ACCESSORIES ARE MOUNTED CORRECTLY AND THAT THE SECURING ELEMENTS (HANDLE SCREWS, CATCHES, LEVERS, ETC.) ARE CLOSED AND FIRMLY TIGHTENED (IFU 1130.53 REV. 9, PAGE 12). IN SUMMARY, AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED ISSUE, THE HEADREST DETACHMENT CAUSING THE HYPEREXTENSION IN THE PATIENT¿S NECK, IS RELATED TO USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE FULL UNIQUE IDENTIFIER (UDI) # INFORMATION AND MANUFACTURING DATE IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D1 BRAND NAME, D2 COMMON DEVICE NAME, D4 VERSION OR MODEL #, D4 CATALOG #, D4 SERIAL #, D4 UNIQUE IDENTIFIER (UDI) #, D10 CONCOMITANT PRODUCTS, H4 DEVICE MANUFACTURE DATE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLES ¿ 113112B0 - BETASTAR MOBILE OPERATING TABLE USED WITH 113053B0 - HEAD REST WITH DOUBLE ARTICULATION. IT WAS STATED THE HEAD REST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. ACCORDING TO INFORMATION PROVIDED, AN INITIAL INSPECTION OF THE SURGICAL TABLE WAS CARRIED OUT, THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE COLUMN COMMAND, WHICH WORKED CORRECTLY. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEAD REST DETACHING AND CAUSING THE HYPEREXTENSION IN PATIENT¿S NECK, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR ACCESSORIES 113053B0 - HEAD REST WITH DOUBLE ARTICULATION USED WITH 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THAT THE HEADREST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY, CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEADREST DETACHMENT CAUSING THE HYPEREXTENSION IN THE PATIENT¿S NECK, WAS TO REOCCUR. PREVIOUS D1 BRAND NAME: BETASTAR MOBILE OPERATING TABLE. CORRECTED D1 BRAND NAME: HEAD REST. PREVIOUS D2 COMMON DEVICE NAME: FQO - TABLE, OPERATING-ROOM, AC-POWERED. CORRECTED D2 COMMON DEVICE NAME: BWN ¿ TABLE AND ATTACHMENTS, OPERATING-ROOM. PREVIOUS D4 VERSION OR MODEL #: 113112B0. CORRECTED D4 VERSION OR MODEL #: 113053B0. PREVIOUS D4 CATALOG #: 113112B0. CORRECTED D4 CATALOG #: N/A. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: N/A. PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS D10 CONCOMITANT PRODUCTS: 113053B0 HEAD REST WITH DOUBLE ARTICULATION. CORRECTED D10 CONCOMITANT PRODUCTS: 113112B0 BETASTAR MOBILE OPERATING TABLE. PREVIOUS H4 DEVICE MANUFACTURE DATE: 04/30/2010. CORRECTED H4 DEVICE MANUFACTURE DATE: N/A.

Description of Event or Problem

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLES ¿ 113112B0 - BETASTAR MOBILE OPERATING TABLE USED WITH 113053B0 - HEAD REST WITH DOUBLE ARTICULATION. IT WAS STATED THE HEAD REST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. ACCORDING TO INFORMATION PROVIDED, AN INITIAL INSPECTION OF THE SURGICAL TABLE WAS CARRIED OUT, THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE COLUMN COMMAND, WHICH WORKED CORRECTLY. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEAD REST DETACHING AND CAUSING THE HYPEREXTENSION IN PATIENT¿S NECK, WAS TO REOCCUR.

Additional Manufacturer Narrative

ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF B3 DATE OF EVENT, B5 DESCRIBE EVENT AND PROBLEM, G3 DATE RECEIVED BY MANUFACTURER FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B3 DATE OF EVENT: 12/10/2024. CORRECTED B3 DATE OF EVENT: 12/04/2024. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLES ¿ 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THE HEAD REST OF THE SURGICAL TABLE CAME LOOSE IN THE MIDDLE OF SURGERY. ACCORDING TO INFORMATION PROVIDED, AN INITIAL INSPECTION OF THE SURGICAL TABLE WAS CARRIED OUT, THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE COLUMN COMMAND, WHICH WORKED CORRECTLY. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO PATIENT¿S FALL, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLES ¿ 113112B0 - BETASTAR MOBILE OPERATING TABLE USED WITH 113053B0 - HEAD REST WITH DOUBLE ARTICULATION. IT WAS STATED THE HEAD REST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. ACCORDING TO INFORMATION PROVIDED, AN INITIAL INSPECTION OF THE SURGICAL TABLE WAS CARRIED OUT, THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE COLUMN COMMAND, WHICH WORKED CORRECTLY. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEAD REST DETACHING AND CAUSING THE HYPEREXTENSION IN PATIENT¿S NECK, WAS TO REOCCUR. PREVIOUS G3 DATE RECEIVED BY MANUFACTURER: 12/16/2024. CORRECTED G3 DATE RECEIVED BY MANUFACTURER 12/12/2024.

Description of Event or Problem

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLES ¿ 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THE HEAD REST OF THE SURGICAL TABLE CAME LOOSE IN THE MIDDLE OF SURGERY. ACCORDING TO INFORMATION PROVIDED, AN INITIAL INSPECTION OF THE SURGICAL TABLE WAS CARRIED OUT, THE CORRECT OPERATION OF ALL TABLE MOVEMENTS WAS VERIFIED FROM THE CONTROL AND THE COLUMN COMMAND, WHICH WORKED CORRECTLY. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO PATIENT¿S FALL, WAS TO REOCCUR.

Additional Manufacturer Narrative

INITIAL REPORTER: (B)(6). EVENT SITE NAME: (B)(4). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.