SPINAL COLUMN POSITIONING DEVICE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1A INITIAL REPORTER: (B)(6). E1I EVENT SITE TELEPHONE: (B)(6). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022.

Description of Event or Problem

ON 27TH AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES: 100722A0, SPINAL COLUMN POSITIONING DEVICE. ON 28TH AUGUST 2024, ADDITIONAL INFORMATION WAS RECEIVED. AS IT WAS STATED, THE BASE OF THE POSITIONING DEVICE BUCKLED DURING PREPARATION OF THE ANESTHETIZED PATIENT FOR POST-OP REPOSITIONING. THE INCIDENT OCCURRED DURING AN ADJUSTMENT OF THE TABLE HEIGHT. THE PATIENT SLIPPED HEAD-ON AND SUFFERED BRUISES ON HIS FACE. MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS NOT PROVIDED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THERE WERE NO ANTI-SLIP MATS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT FALLING OFF THE OPERATING TABLE, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 100722A0 - SPINAL COLUMN POSITIONING DEVICE. AS IT WAS STATED, THE BASE OF THE POSITIONING DEVICE BUCKLED DURING THE PREPARATION OF THE ANESTHETIZED PATIENT FOR POST-OP REPOSITIONING. THE INCIDENT OCCURRED DURING AN ADJUSTMENT OF THE TABLE HEIGHT. THE PATIENT SLIPPED HEAD-ON AND SUFFERED BRUISES ON HIS FACE. MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS NOT PROVIDED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THERE WERE NO ANTI-SLIP MATS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT FALLING OFF THE OPERATING TABLE, WAS TO REOCCUR. 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 THE MALFUNCTION WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT IN THE PAST THERE WAS NO SERIOUS INJURY TO THE PATIENT OR USER WHEN THIS PARTICULAR ISSUE OCCURRED. THE COMPLAINT IS A SINGLE AND ISOLATED CASE. THE AFFECTED GETINGE DEVICE HAS BEEN RETURNED FOR EVALUATION AND REPAIR. THE ROOT CAUSE ANALYSIS WAS PERFORMED BY THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE. IT WAS ASSESSED THAT THE DEVICE SHOWED VISUALLY RECOGNIZABLE SIGNS OF WEAR. IT COULD BE SEEN THAT THE LOCKING MECHANISM OF THE SLIDE RAIL HAD BEEN REMOVED AND WAS NO LONGER PRESENT. THE SME CHECKED THE ADJUSTMENT OF THE FOOT REST AS DESCRIBED IN THE TEST INSTRUCTIONS AND IT WORKED ACCORDING TO THE SPECIFICATION. DURING THE TABLE TOP TRANSFER TEST, IT WAS OBSERVED THAT THE LOCKING MECHANISM ON THE ESG CLAMP 31019629 NO LONGER WORKED ON ONE SIDE. IT GOT STUCK AND DID NOT LOCK THE ACCESSORY. THE AFFECTED PART WAS REPLACED. DURING THE REINSPECTION AT THE REPAIR CENTER, THE IN-HOUSE TECHNICIAN NOTICED THAT THE FRAME MOUNT WAS WARPED. THIS COULD NO LONGER BE REPAIRED AND THE PRODUCT WAS SCRAPPED. DURING THE PERFORMED EVALUATION, THE BENT MOUNT WAS FOUND. ACCORDING TO THE SME¿S ASSESSMENT, THE DEFORMATION OF THE MOUNT COULD HAVE BEEN CAUSED BY DAMAGE DUE TO A FALL OR COLLISION. THE ISSUE MIGHT HAVE BEEN THE RESULT OF THE REPORTED INCIDENT. HOWEVER, IT CANNOT BE EXCLUDED THAT THE MALFUNCTION HAD BEEN PRESENT BEFORE THE EVENT AND POTENTIALLY RESULTED IN THE LOCKING MECHANISM NOT BEING ACTIVE. IN THE INSTRUCTION FOR USE THE USER IS WARNED TO AVOID COLLISIONS WITH OTHER OBJECTS IN THE ROOM (GA100722EN05, PAGE 2) AND TO CHECK THE CONDITION OF THE PRODUCT BEFORE EACH USE. IF DEFECTS ARE DETECTED THE PRODUCT MUST NOT BE USED ANY LONGER (GA100722EN05, PAGE 13). AS IT WAS FURTHER CONFIRMED, THE ADJUSTMENT OF THE FOOT REST WORKED ACCORDING TO THE SPECIFICATION. FOLLOWING CONSULTATION WITH THE SME, IT WAS ASSESSED THAT THE MOST PROBABLE ROOT CAUSE WAS INCORRECT ADJUSTMENT OF THE FOOT SUPPORT OR BRACE NOT FIXED CORRECTLY. THE CORRECT MOUNTING OF THE DEVICE AND GENERAL USE OF THE DEVICE ARE DESCRIBED IN THE INSTRUCTION FOR USE (GA100722EN05, PAGE 4-5 AND 8-10). IN SUMMARY, BASED ON ALL AVAILABLE INFORMATION, IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR. 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, D4 SERIAL # AND H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 27TH AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 100722A0 - SPINAL COLUMN POSITIONING DEVICE. ON 28TH AUGUST 2024, ADDITIONAL INFORMATION WAS RECEIVED. AS IT WAS STATED, THE BASE OF THE POSITIONING DEVICE BUCKLED DURING PREPARATION OF THE ANESTHETIZED PATIENT FOR POST-OP REPOSITIONING. THE INCIDENT OCCURRED DURING AN ADJUSTMENT OF THE TABLE HEIGHT. THE PATIENT SLIPPED HEAD-ON AND SUFFERED BRUISES ON HIS FACE. MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS NOT PROVIDED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THERE WERE NO ANTI-SLIP MATS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT FALLING OFF THE OPERATING TABLE, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 100722A0 - SPINAL COLUMN POSITIONING DEVICE. AS IT WAS STATED, THE BASE OF THE POSITIONING DEVICE BUCKLED DURING PREPARATION OF THE ANESTHETIZED PATIENT FOR POST-OP REPOSITIONING. THE INCIDENT OCCURRED DURING AN ADJUSTMENT OF THE TABLE HEIGHT. THE PATIENT SLIPPED HEAD-ON AND SUFFERED BRUISES ON HIS FACE. MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS NOT PROVIDED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THERE WERE NO ANTI-SLIP MATS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT FALLING OFF THE OPERATING TABLE, WAS TO REOCCUR. PREVIOUS D4 SERIAL #: (B)(4). CORRECTED D4 SERIAL #: (B)(4). PREVIOUS H6 COMPONENT CODES: OTHERS/INSUFFICIENT INFORMATION//4776. CORRECTED H6 COMPONENT CODES: MECHANICAL/MOUNT//887. SAFETY/LOCKING MECHANISM//3083.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 100722A0 - SPINAL COLUMN POSITIONING DEVICE. AS IT WAS STATED, THE BASE OF THE POSITIONING DEVICE BUCKLED DURING PREPARATION OF THE ANESTHETIZED PATIENT FOR POST-OP REPOSITIONING. THE INCIDENT OCCURRED DURING AN ADJUSTMENT OF THE TABLE HEIGHT. THE PATIENT SLIPPED HEAD-ON AND SUFFERED BRUISES ON HIS FACE. MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS NOT PROVIDED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THERE WERE NO ANTI-SLIP MATS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT FALLING OFF THE OPERATING TABLE, WAS TO REOCCUR.