TRACTION DEVICE

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES. LATER ON, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE INCIDENT WITH THE PATIENT OCCURRED ON THE 141901JC EXTENSION DEVICE. AFTERWARD, FURTHER DETAILS WERE PROVIDED. AS IT WAS STATED, THE 31138834 TENSION BLOCK SHORT WELDING GROUP WAS BROKEN AND LOCKING/UNLOCKING WAS NOT POSSIBLE. CONSEQUENTLY, THE TRACTION DEVICE HAD TO BE REPLACED. AS A RESULT, THE PROCEDURE WAS DELAYED. THE ISSUE OCCURRED DURING FEMUR FRACTURE SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY UNINTENDED MOTION OF THE DEVICE OCCURRING WITH THE PATIENT ON THE TABLE, WAS TO REOCCUR. THE INVESTIGATED CASE WAS REVIEWED WITH A SUBJECT MATTER EXPERT, WHO CONFIRMED THAT ALL POSSIBILITIES FOR ROOT CAUSE ANALYSIS HAVE BEEN EXHAUSTED. THIS IS DUE TO THE FACT THAT THE AFFECTED PART IS NO LONGER AVAILABLE, THE ANALYSIS IS IMPOSSIBLE TO PERFORM AND THE EXACT ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED. IT IS SUSPECTED THAT THIS IS AN ISOLATED DEFECT, WHICH COULD BE GENERATED BY OVERLOADING. THE AFFECTED DEVICE WAS REPAIRED BY A HOSPITAL ENGINEER, THE PART WAS FIXED IN THE LOCAL MARKET. THE DEVICE WAS RESTORED TO FULL WORKING ORDER AND RETURNED TO SERVICE. NO ADDITIONAL CUSTOMER PRODUCT COMPLAINTS REGISTERED FOR OVER ONE YEAR. BASED ON THE INVESTIGATION, IT WAS CONCLUDED THAT AT THE TIME OF THE INCIDENT, THE DEVICES WERE BEING USED FOR THE PATIENT'S TREATMENT AND THEREFORE WERE DIRECTLY INVOLVED IN THE REPORTED EVENT. AS THE MALFUNCTION OCCURRED DURING THE SURGERY, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR INCIDENT OCCURRED. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE UNINTENDED MOTION OF THE DEVICE OCCURRING WITH THE PATIENT ON THE TABLE, COULD NOT BE IDENTIFIED, THE ROOT CAUSE REMAINS UNKNOWN AND IMPOSSIBLE TO DEFINE. 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 CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D1 BRAND NAME, D4 CATALOG #, D4 SERIAL #, D4 UNIQUE IDENTIFIER (UDI) #, E2 HEALTH PROFESSIONAL, E3 OCCUPATION, H4 DEVICE MANUFACTURE DATE AND H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 18TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES. ON 3RD APRIL 2024, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE INCIDENT WITH THE PATIENT OCCURRED ON 141901JC EXTENSION DEVICE. LATER ON, FURTHER DETAILS WERE PROVIDED. AS IT WAS STATED, THE 31138834 TENSION BLOCK SHORT WELDING GROUP WAS BROKEN AND LOCKING/UNLOCKING WAS NOT POSSIBLE. CONSEQUENTLY, THE TRACTION DEVICE HAD TO BE REPLACED. AS A RESULT, THE PROCEDURE WAS DELAYED. THE ISSUE OCCURRED DURING FEMUR FRACTURE SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES. LATER ON, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE INCIDENT WITH THE PATIENT OCCURRED ON THE 141901JC EXTENSION DEVICE. AFTERWARD, FURTHER DETAILS WERE PROVIDED. AS IT WAS STATED, THE 31138834 TENSION BLOCK SHORT WELDING GROUP WAS BROKEN AND LOCKING/UNLOCKING WAS NOT POSSIBLE. CONSEQUENTLY, THE TRACTION DEVICE HAD TO BE REPLACED. AS A RESULT, THE PROCEDURE WAS DELAYED. THE ISSUE OCCURRED DURING FEMUR FRACTURE SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY UNINTENDED MOTION OF THE DEVICE OCCURRING WITH THE PATIENT ON THE TABLE, WAS TO REOCCUR. PREVIOUS D1 BRAND NAME: EXTENSION DEVICE. CORRECTED D1 BRAND NAME: TRACTION DEVICE. PREVIOUS D4 CATALOG #: 141901JC. CORRECTED D4 CATALOG #: N/A. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS E2 HEALTH PROFESSIONAL?: YES CORRECTED E2 HEALTH PROFESSIONAL?: NO. PREVIOUS E3 OCCUPATION: PHYSICIAN. CORRECTED E3 OCCUPATION: BIOMEDICAL ENGINEER. PREVIOUS H4 DEVICE MANUFACTURE DATE: 01/03/2022. CORRECTED H4 DEVICE MANUFACTURE DATE: 10/08/2021. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: ACTIVATION, POSITIONING OR SEPARATION. PROBLEM/POSITIONING PROBLEM / POSITIONING FAILURE/1158, MATERIAL INTEGRITY. PROBLEM/BREAK/SOLDER JOINT FRACTURE/2324. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/STRUCTURAL. PROBLEM/DIFFICULT TO OPEN OR CLOSE/2921, MECHANICAL PROBLEM/UNINTENDED MOVEMENT//3026.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES. LATER ON, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE INCIDENT WITH THE PATIENT OCCURRED ON THE 141901JC EXTENSION DEVICE. AFTERWARD, FURTHER DETAILS WERE PROVIDED. AS IT WAS STATED, THE 31138834 TENSION BLOCK SHORT WELDING GROUP WAS BROKEN AND LOCKING/UNLOCKING WAS NOT POSSIBLE. CONSEQUENTLY, THE TRACTION DEVICE HAD TO BE REPLACED. AS A RESULT, THE PROCEDURE WAS DELAYED. THE ISSUE OCCURRED DURING FEMUR FRACTURE SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY UNINTENDED MOTION OF THE DEVICE OCCURRING WITH THE PATIENT ON THE TABLE, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : 3RD PARTY EVALUATION.

Description of Event or Problem

ON 18TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES. ON 3RD APRIL 2024, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE INCIDENT WITH THE PATIENT OCCURRED ON 141901JC EXTENSION DEVICE. LATER ON, FURTHER DETAILS WERE PROVIDED. AS IT WAS STATED, THE 31138834 TENSION BLOCK SHORT WELDING GROUP WAS BROKEN AND LOCKING/UNLOCKING WAS NOT POSSIBLE. CONSEQUENTLY, THE TRACTION DEVICE HAD TO BE REPLACED. AS A RESULT, THE PROCEDURE WAS DELAYED. THE ISSUE OCCURRED DURING FEMUR FRACTURE SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.