TRANSPORTER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME (E1): (B)(6).

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS ¿ 114662A0 - TRANSPORTER. AS IT WAS STATED, DUE TO THE ISSUE WITH HEIGHT ADJUSTMENT THE TRANSFER OF THE TABLE TOP FROM THE TRANSPORTER ONTO THE COLUMN WAS NOT POSSIBLE. CONSEQUENTLY, THE SURGERY WAS CANCELLED. ON (B)(6) 2023, IT HAS BEEN CONFIRMED THAT THE PATIENT HAD ALREADY BEEN ANESTHETIZED FOR THE PROCEDURE WHEN THE ISSUE OCCURRED. THEREFORE, IT HAS BEEN CONSIDERED AS A DELAY IN TREATMENT. ACCORDING TO THE PROVIDED INFORMATION, THE SURGERY WAS PERFORMED AT A LATER DATE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY INABILITY TO TRANSFER THE TABLE TOP ONTO THE COLUMN LEADING TO DELAY IN TREATMENT AND PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS ¿ 114662A0 ¿ TRANSPORTER. AS IT WAS STATED, DUE TO THE ISSUE WITH HEIGHT ADJUSTMENT THE TRANSFER OF THE TABLE TOP FROM THE TRANSPORTER ONTO THE COLUMN WAS NOT POSSIBLE. CONSEQUENTLY, THE SURGERY WAS CANCELED. ON (B)(6) 2023, IT WAS CONFIRMED THAT THE PATIENT HAD ALREADY BEEN ANESTHETIZED FOR THE PROCEDURE WHEN THE ISSUE OCCURRED. THEREFORE, IT HAS BEEN CONSIDERED AS A DELAY IN TREATMENT. ACCORDING TO THE PROVIDED INFORMATION, THE SURGERY WAS PERFORMED AT A LATER DATE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO TRANSFER THE TABLE TOP ONTO THE COLUMN LEADING TO DELAY IN TREATMENT AND PROLONGED ANESTHESIA TIME, WAS TO REOCCUR. THE AFFECTED TRANSPORTER HAS BEEN EVALUATED BY THE SERVICE TECHNICIAN. THE EVALUATION REVEALED THAT THE REPORTED ISSUE WAS CAUSED BY THE MALFUNCTION OF THE HYDRAULIC PUMP (PART NUMBER 31155041). THE DAMAGE WAS RELATED TO TORN OFF FASTENING SCREWS ON THE PUMP HOUSING. ACCORDING TO THE TECHNICIAN, THIS DAMAGE WAS NOT FORESEEABLE. THE AFFECTED PART WAS REPLACED BY THE TECHNICIAN WHICH RESOLVED THE PROBLEM. THE AFFECTED GETINGE DEVICE WAS MANUFACTURED ON 08/07/2007. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS DATABASE REVEALED THAT IN THE PAST THERE WERE NO CUSTOMER PRODUCT COMPLAINTS RELATED TO THE HYDRAULIC PUMP MALFUNCTION. THE TECHNICIAN PROVIDED INFORMATION THAT THE IDENTIFIED MALFUNCTION OF THE PUMP WAS MOST PROBABLY RELATED TO THE AGE OF THE DEVICE. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT AND, THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OF THE HYDRAULIC PUMP WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT NO MALFUNCTIONS WITH THE HYDRAULIC PUMP WERE PREVIOUSLY REPORTED SO IT CAN BE SUSPECTED THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE ISSUE WITH HEIGHT ADJUSTMENT DURING THE TRANSFER OF THE TABLE TOP FROM THE TRANSPORTER ONTO THE COLUMN WHICH CAUSED CANCELED SURGERY AND LED TO THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, IS WEAR OF THE PART RELATED TO PROLONGED USAGE. THERE WERE NO SIMILAR REPORTABLE CUSTOMER PRODUCT COMPLAINTS RELATED TO THIS ISSUE INVESTIGATED HERE, THEREFORE THE ISSUE 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 AND H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS H4 DEVICE MANUFACTURE DATE: 09/01/2007 CORRECTED H4 DEVICE MANUFACTURE DATE: 08/07/2007 PREVIOUS H6 COMPONENT CODES: MECHANICAL/PUMP/925 CORRECTED H6 COMPONENT CODES: MECHANICAL/FASTENER/SCREW /568.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).