HEAD REST WITH DOUBLE ARTICULATION, EU

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH 113069A0 - HEAD REST WITH DOUBLE ARTICULATION, EU. AT THE END OF SURGICAL PROCEDURE (OROPHARYNGECTOMY) DURING THE REMOVAL OF THE COVER PRESENT UNDER THE PATIENT'S HEAD, THE HEAD REST DROPPED TO THE LOWEST POSITION. THE PATIENT'S HEAD WAS HELD BY THE SURGEON AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN THE ABUNDANCE OF CAUTION AS SERIOUS INJURY IN CASE OF EVENT RECURRENCE CANNOT BE EXCLUDED. THE AFFECTED HEAD REST WAS EVALUATED BY THE GETINGE PRODUCT SPECIALIST AND NO MALFUNCTION WITH THE DEVICE WAS FOUND. THE PICTURES OF THE AFFECTED HEAD REST PROVIDED BY THE CUSTOMER REVEALED THAT THE STERILE COVERS WERE ATTACHED TO THE HEAD REST LEVER. DURING REMOVING THE STERILE COVER, THE LEVER WAS ACCIDENTALLY RELEASED AND THE HEAD REST DROPPED TO THE LOWEST POSITION. AFTER CONSULTATION WITH MEDICAL EXPERT IT WAS ESTABLISHED THAT THE USER SHOULD BE CAREFUL DURING RELEASING THE DRAPES FROM THE PATIENT¿S HEAD AND THE HEAD REST AFTER SURGERY AND ENSURE THAT SUCH EVENT WILL NOT HAPPEN. THE USER SHOULD BE ALSO AWARE OF THE DESIGN OF THE PRODUCT AND THE PLACEMENT OF THE HANDLE AS THE DEVICE MAY ONLY BE OPERATED BY MEDICALLY TRAINED STAFF WITHIN THE OR ENVIRONMENT. 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 HEAD REST WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. IN SUMMARY AND AS A RESULT OF PERFORMED ROOT CAUSE EVALUATION IT CAN BE CONCLUDED THAT ALTHOUGH THE WAY THE USER COVERED THE DEVICE WITH THE DRAPES AND ATTACHED IT TO THE LEVER IS NOT FORBIDDEN PER THE RELEVANT IFU IT IS CONSIDERED THAT A PRIMARY FACTOR TO THIS SPECIFIC SITUATION OCCURRENCE IS RELATED TO THE OPERATIONAL CONTEXT FOR THIS USER. THERE WERE NO SIMILAR COMPLAINTS FOUND RELATED TO THIS ISSUE INVESTIGATED HERE. THE FAILURE RATIO IS (B)(4)% FOR THE ISSUE INVESTIGATED HEREIN REGARDING TO THE HEAD REST. THE FAILURE RATIO FOR THE CONFIGURATION OF THE HEAD REST AND MODULAR UNIVERSAL TABLE TOP IS (B)(4).%. 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 B5 DESCRIBE EVENT OR PROBLEM AND H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 2ND NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR HEAD RESTS ¿ 113069A0 - HEAD REST WITH DOUBLE ARTICULATION, EU. IT WAS STATED THAT THE FIELD ADHESIVES WERE PRESENT ON THE RELEASE HANDLE. AT THE END OF SURGICAL PROCEDURE (OROPHARYNGECTOMY) DURING REMOVAL OF THE COVER PRESENT UNDER THE PATIENT'S HEAD, THE HANDLE WAS ACCIDENTALLY RELEASED RESULTING IN 113069A0 - HEAD REST DROP TO THE LOWEST POSITION. THE PATIENT'S HEAD WAS HELD BY THE SURGEON AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS SERIOUS INJURY IN CASE OF EVENT RECURRENCE CANNOT BE EXCLUDED. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 2ND NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR HEAD RESTS ¿ 113069A0 - HEAD REST WITH DOUBLE ARTICULATION, EU. THE CUSTOMER PROVIDED INFORMATION THAT THE HEAD REST WAS PROBABLY USED WITH 115030B0 - MODULAR UNIVERSAL TABLE TOP, SN 2083. AS IT WAS STATED, THE FIELD ADHESIVES WERE PRESENT ON THE RELEASE HANDLE. AT THE END OF THE SURGICAL PROCEDURE (OROPHARYNGECTOMY) DURING THE REMOVAL OF THE COVER PRESENT UNDER THE PATIENT'S HEAD, THE HANDLE WAS ACCIDENTALLY RELEASED RESULTING IN THE HEAD REST DROP TO THE LOWEST POSITION. THE PATIENT'S HEAD WAS HELD BY THE SURGEON AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FAST UNINTENDED MOVEMENT OF HEAD REST WHICH COULD POTENTIALLY LEAD TO SIGNIFICANT CHANGE IN THE POSITION OF PATIENT'S HEAD, WAS TO REOCCUR. PREVIOUS H6 COMPONENT CODES: MECHANICAL/MOUNT//887. CORRECTED H6 COMPONENT CODES: SAFETY/LOCKING MECHANISM//3083.

Description of Event or Problem

ON 2ND NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR HEAD RESTS ¿ 113069A0 - HEAD REST WITH DOUBLE ARTICULATION, EU. THE CUSTOMER PROVIDED INFORMATION THAT THE HEAD REST WAS PROBABLY USED WITH 115030B0 - MODULAR UNIVERSAL TABLE TOP, SN (B)(6). AS IT WAS STATED, THE FIELD ADHESIVES WERE PRESENT ON THE RELEASE HANDLE. AT THE END OF THE SURGICAL PROCEDURE (OROPHARYNGECTOMY) DURING THE REMOVAL OF THE COVER PRESENT UNDER THE PATIENT'S HEAD, THE HANDLE WAS ACCIDENTALLY RELEASED RESULTING IN THE HEAD REST DROP TO THE LOWEST POSITION. THE PATIENT'S HEAD WAS HELD BY THE SURGEON AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FAST UNINTENDED MOVEMENT OF HEAD REST WHICH COULD POTENTIALLY LEAD TO SIGNIFICANT CHANGE IN THE POSITION OF PATIENT'S HEAD, WAS TO REOCCUR.

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 2ND NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR HEAD RESTS ¿ 113069A0 - HEAD REST WITH DOUBLE ARTICULATION, EU. IT WAS STATED THAT THE FIELD ADHESIVES WERE PRESENT ON THE RELEASE HANDLE. AT THE END OF SURGICAL PROCEDURE (OROPHARYNGECTOMY) DURING REMOVAL OF THE COVER PRESENT UNDER THE PATIENT'S HEAD, THE HANDLE WAS ACCIDENTALLY RELEASED RESULTING IN 113069A0 - HEAD REST DROP TO THE LOWEST POSITION. THE PATIENT'S HEAD WAS HELD BY THE SURGEON AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS SERIOUS INJURY IN CASE OF EVENT RECURRENCE CANNOT BE EXCLUDED.