BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON FIBRE TABLE TOP, NEURO

    MDR report key: 18995034 · Received March 28, 2024

    Report

    Report Number
    8010652-2024-00045
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MAQUET GMBH
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: (B)(6) MEDICAL CENTER.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 118016A7 CARBON FIBRE TABLE TOP, NEURO. AS IT WAS STATED, THE ERROR CODE 174-9 (TABLE TOP POSITION ERROR) OCCURRED AND THE LINKED ANGIOGRAPHIC SYSTEM STOPPED. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AT THE TIME OF TAKING X-RAYS. THE ERROR PREVENTED OPERATION OF THE ANGIOGRAPHIC SYSTEM AND THE PATIENT HAD TO BE MOVED TO ANOTHER OPERATING ROOM. FOLLOWING THE TRANSFER, THE PROCEDURE WAS CONTINUED. THE ISSUE RESULTED IN A DELAY. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS PROBABLY ANESTHETIZED DURING 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 THE PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, 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 WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OCCURRED, 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. A GETINGE TECHNICIAN EVALUATED THE AFFECTED TABLE. THE INSPECTION OF THE OPERATING TABLE REVEALED THE DEFECT OF THE 2310884 POTENTIOMETER HHIR1705M R2K. NO PROBLEMS WITH THE LATERAL SHIFT DRIVE, LONGITUDINAL DRIVE, OTHER SENSORS OR BATTERY WERE FOUND. THE AFFECTED POTENTIOMETER WAS REPLACED AND SENSOR CALIBRATION WAS PERFORMED. ADDITIONALLY, THE LATERAL SHIFT DRIVE AND LONGITUDINAL DRIVE WERE GREASED. AFTER COMPLETING THE NECESSARY REPAIRS, THE DEVICE WAS RETURNED TO SERVICE. THE AFFECTED PART WAS RETURNED TO THE MANUFACTURER FOR THE ROOT CAUSE ANALYSIS. ACCORDING TO THE PERFORMED INSPECTION, NO FAULT COULD BE VISUALLY RECOGNIZED ON THE POTENTIOMETER. MECHANICALLY, THE POTENTIOMETER BOLT COULD BE TURNED EASILY. FUNCTIONAL TEST WAS NOT TECHNICALLY POSSIBLE FOR THE PROCESS ASSURANCE. THEREFORE, THE AFFECTED PART WAS FORWARDED TO THE SUPPLIER. THE SUPPLIER¿S ASSESSMENT WAS DOCUMENTED IN THE 8D REPORT. ACCORDING TO THE EVALUATION, THE POTENTIOMETER WAS WORN DUE TO AGE AND USE AND WAS WELL OUTSIDE THE WARRANTY PERIOD (15 MONTHS) AT THE TIME OF INSPECTION. BASED ON THE INFORMATION PROVIDED BY THE SALES AND SERVICE UNIT AS WELL AS THE DATABASE REVIEW, THE AFFECTED PART WAS REPLACED 9 DAYS BEFORE THE INCIDENT. THE PROCESS ASSURANCE TEAM WAS CONTACTED TO CLARIFY THE AGE OF THE AFFECTED PART AND EXPLAINED THAT IT WAS POSSIBLE THAT THE PART HAD BEEN STORED LONGER THAN INTENDED. HOWEVER, AS THE AFFECTED PART WAS SCRAPPED AFTER THE INVESTIGATION IT COULD NO LONGER BE VERIFIED. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICAL SUPPORT, IT IS POSSIBLE TO DAMAGE THE POTENTIOMETER DURING THE REPAIR. THE CHAPTER 5.13 IN THE RELEVANT SERVICE MANUAL TR 118016XX EN 08 DESCRIBES HOW TO CORRECTLY REPLACE THE 2310884 POTENTIOMETER HHIR1705M R2K. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT BASED ON AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, COULD BE RELATED TO SERVICE-BUSINESS ISSUE. 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 UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D4 SERIAL #, H4 DEVICE MANUFACTURE DATE AND H6 HEALTH EFFECT ¿ IMPACT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 14TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 118016A7 CARBON FIBRE TABLE TOP, NEURO. AS IT WAS STATED, THE ERROR CODE 174-9 (TABLE TOP POSITION ERROR) OCCURRED AND THE LINKED ANGIOGRAPHIC SYSTEM STOPPED. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AT THE TIME OF TAKING X-RAYS. THE ERROR PREVENTED OPERATION OF THE ANGIOGRAPHIC SYSTEM AND THE PATIENT HAD TO BE MOVED TO ANOTHER OPERATING ROOM. FOLLOWING THE TRANSFER, THE PROCEDURE WAS CONTINUED. THE ISSUE RESULTED IN A DELAY. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS PROBABLY ANESTHETIZED DURING 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 THE 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 TABLE TOPS 118016A7 CARBON FIBRE TABLE TOP, NEURO. AS IT WAS STATED, THE ERROR CODE 174-9 (TABLE TOP POSITION ERROR) OCCURRED AND THE LINKED ANGIOGRAPHIC SYSTEM STOPPED. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AT THE TIME OF TAKING X-RAYS. THE ERROR PREVENTED OPERATION OF THE ANGIOGRAPHIC SYSTEM AND THE PATIENT HAD TO BE MOVED TO ANOTHER OPERATING ROOM. FOLLOWING THE TRANSFER, THE PROCEDURE WAS CONTINUED. THE ISSUE RESULTED IN A DELAY. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS PROBABLY ANESTHETIZED DURING 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 THE PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, WAS TO REOCCUR. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS H4 DEVICE MANUFACTURE DATE: 02/01/2019. CORRECTED H4 DEVICE MANUFACTURE DATE: 01/23/2019. PREVIOUS H6 HEALTH EFFECT IMPACT CODES: SURGICAL INTERVENTION/PROLONGED SURGERY// 4632. CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: DELAY TO TREATMENT/ THERAPY/// 4604.

    Description of Event or Problem · 0

    ON 14TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 118016A7 - CARBON FIBRE TABLE TOP, NEURO. AS IT WAS STATED, THE ERROR CODE 174-9 (TABLE TOP POSITION ERROR) OCCURRED AND THE LINKED ANGIOGRAPHIC SYSTEM STOPPED. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AT THE TIME OF TAKING X-RAYS. THE ERROR PREVENTED OPERATION OF THE ANGIOGRAPHIC SYSTEM AND THE PATIENT HAD TO BE MOVED TO ANOTHER OPERATING ROOM. FOLLOWING THE TRANSFER, THE PROCEDURE WAS CONTINUED. THE ISSUE RESULTED IN A DELAY. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS PROBABLY ANESTHETIZED DURING 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 THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 118016A7 CARBON FIBRE TABLE TOP, NEURO. AS IT WAS STATED, THE ERROR CODE 174-9 (TABLE TOP POSITION ERROR) OCCURRED AND THE LINKED ANGIOGRAPHIC SYSTEM STOPPED. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AT THE TIME OF TAKING X-RAYS. THE ERROR PREVENTED OPERATION OF THE ANGIOGRAPHIC SYSTEM AND THE PATIENT HAD TO BE MOVED TO ANOTHER OPERATING ROOM. FOLLOWING THE TRANSFER, THE PROCEDURE WAS CONTINUED. THE ISSUE RESULTED IN A DELAY. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS PROBABLY ANESTHETIZED DURING 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 THE PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, WAS TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719629 CARBON FIBRE TABLE TOP, NEURO TABLE, RADIOLOGIC KXJ MAQUET GMBH 118016A7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ANGIOGRAPHY DEVICE.