HEAD PLATE ADAPTOR

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100207A0 HEAD PLATE ADAPTOR USED WITH THE ALPHAMAXX MOBILE OPERATING TABLE WITH CATALOG NUMBER 113312B3 SERIAL NUMBER (B)(6). AS IT WAS STATED, SUDDEN DROP OF THE HEADREST OCCURRED DURING SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED NECK PAIN. THE EXAMINATION OF THE PATIENT WAS PERFORMED AND IT WAS CONCLUDED THAT THERE WAS NO INJURY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FAST UNINTENDED MOVEMENT OF HEADREST LEADING TO CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN. THE TECHNICIAN COULD NOT FIND ANY ISSUE WITH THE HEAD PLATE ADAPTER. HE SUSPECTED THAT THE HANDLE SCREW AND PENDULUM HANDLE MAY HAVE COME INTO CONTACT WITH THE OPERATOR, ACTIVATE THE LOCKING ELEMENTS AND CONSEQUENTLY CAUSE THE HEADREST TO DROP. AFTER THE INSPECTION THE DEVICE WAS RELEASED TO USAGE. THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE CONFIRMED THAT UNDER THE REPORTED CIRCUMSTANCES, THE ACCIDENTAL OPENING OF THE HANDLE SCREW AND PENDULUM HANDLE COULD BE A POSSIBLE REASON FOR THE HEADREST SUDDEN DROP. FURTHERMORE IN THE RISK ANALYSIS FILE RA_1002_07A0_V01, DERIVED 2016-12-19 IN POINT 10 RELATED TO THE UNINTENTIONAL MOVEMENTS, THERE IS AN MITIGATION FACTOR REGARDING DESIGN OF THE CONTROLS OF THE HOLD-OPEN DEVICE IN SUCH WAY THAT ACCIDENTAL OPENING IS PREVENTED. HOWEVER IT IS INDICATED, THAT THE USER COULD STILL DELIBERATELY OPEN AN ELEMENT. INCORRECT USE, SUCH AS INADEQUATE PATIENT POSITIONING (INCLUDING RE-POSITIONING DURING THE PROCEDURE), EXCEEDING LIMITS, NEGLIGENCE IN USE, ETC., CAN LEAD TO DAMAGE THAT CANNOT BE PREVENTED BY TECHNICAL MEASURES. FURTHER TECHNICAL MEASURES CANNOT REDUCE THE SEVERITY AND / OR PROBABILITY OF OCCURRENCE, AS THE RISK DEPENDS ON THE COOPERATION OF THE USER. IN THE IFU (IFU 1002.07 EN 12, PAGE 12), THE USER IS WARNED THAT IF LOCKING ELEMENTS (ECCENTRIC LEVERS, HANDLE SCREWS, LOCKS, ETC) ARE OPEN THE PRODUCT/ ACCESSORY CAN BE MOVED. IN THE IFU (IFU 1002.07 EN 12, PAGE 12), THERE IS A SAFETY NOTE STATING THAT WHENEVER THE PRODUCT IS MOUNTED AND ADJUSTED, THERE IS A DANGER OF PINCHING AND SHEARING TO THE STAFF, PATIENT AND ACCESSORIES. THE USER SHALL ENSURE THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS. THE USER IS ALSO INFORMED (IFU 1002.07 EN 12, PAGE 13), THAT LOOSE OR LOOSENED SECURING ELEMENTS MAY CAUSE INJURIES. THE USER SHALL CHECK THE FIRM SEATING OF THE LOCKING ELEMENTS. IT IS LIKELY THAT THE USER UTILIZED THE ACCESSORY DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS NO MALFUNCTION OF THE HEAD PLATE ADAPTOR WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. BASED ON ALL AVAILABLE INFORMATION WE ASSUME THAT THE ROOT CAUSE FOR UNINTENDED MOVEMENT, RESULTING IN SUDDEN DROP OF THE HEADREST DURING THE SURGERY WAS MOST LIKELY RELATED TO THE USER ERROR. THE COMPLAINT INVESTIGATED HEREIN IS A SINGLE AND ISOLATED CASE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE 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 CORRECTION OF H4 DEVICE MANUFACTURE DATE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 DEVICE MANUFACTURE DATE: 07/01/2008.

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Description of Event or Problem

ON 17TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100207A0 HEAD PLATE ADAPTOR. AS IT WAS STATED, SUDDEN DROP OF THE HEADREST OCCURRED DURING SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED NECK PAIN. THE EXAMINATION OF THE PATIENT WAS PERFORMED AND IT WAS CONCLUDED THAT THERE WAS NO INJURY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FAST UNINTENDED MOVEMENT OF HEADREST LEADING TO CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.