BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVECARE +SFT SYSTEM

    MDR report key: 8910185 · Received August 20, 2019

    Report

    Report Number
    0001526350-2019-00663
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 20, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE PRODUCT CODE - JOW. DHR/REPAIR RECORD REVIEW: THE DEVICE HISTORY RECORD (DHR) OF ACTIVECARE+SFT UNIT SERIAL NUMBER (B)(4) IS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES. THE DHR FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. UPON REVIEWING MCS LEGACY COMPLAINTS DATA AND DHR IT IS NOTED THAT DEVICE ASSOCIATED WITH SERIAL NUMBER (B)(4) IS PREVIOUSLY REPAIRED 1 TIME FOR INFLATION, BATTERY CHARGING ISSUE AND IT IS RELATED TO PREVIOUS REPORTED EVENT. COMPLAINT HISTORY: USING MCS LEGACY DATA FROM (B)(6) 2018 TO (B)(6) 2019, THERE WERE (B)(4) COMPLAINTS THAT CONTAIN KEYWORD SEARCH USING THE CHARACTER STRING BATTERY BASED ON THE REPORTED EVENT. ABOVE NOTED COMPLAINTS REPRESENT WELL UNDERSTOOD EVENTS THAT HAVE PREVIOUSLY BEEN SUBJECT TO A COMPREHENSIVE, DOCUMENTED COMPLAINT INVESTIGATION. EVEN THOUGH THE BATTERY CHARGING ISSUE IS RELATED TO THE PREVIOUS REPORTED EVENT, WHILE EVALUATING THE DEVICE, BATTERY FAILURE IS NOT NOTED IN BOTH CASES. HENCE NO FURTHER ACTION IS REQUIRED. TECHNICAL REVIEW AND PHYSICAL EVALUATION: ON (B)(6) 2019, IT WAS REPORTED THAT THE DEVICE SCREEN WAS SHOWING LOW BATTERY ALARM. AS PER FOLLOW UP, WHEN UNIT WAS PLUGGED IN, THE LOW BATTERY ALARM KEEP BEEPING INDICATING THE BATTERY WAS DEAD. WHILE EVALUATING THE DEVICE SERVICE TECHNICIAN COULDN'T DUPLICATE THE CONCERN OF REPORTED EVENT BECAUSE THERE WAS NO ISSUE WITH BATTERY . ALSO NOTED BELOW MENTIONED ERRORS. CARRYING STRAP WAS MISSING. ONE WAY VALVE (CHECK VALVE) HAD AIR LEAK AND IT WAS DIRTY. PUMP WIRING WAS FRAYED. SERVICE TECHNICIAN THEN REPLACED THE BELOW MENTIONED COMPONENTS AND CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE DEVICE WAS TESTED AND INSPECTED. CARRYING STRAP (A504A155010). CHECK VALVE (318B001901). GEN B PUMP WIRE (503A001702). SQUARE WARRANTY SEAL (350W000102). SERVICE TECHNICIAN WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE WITH THE DEVICE DURING EVALUATION. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF REPORTED EVENT CANNOT BE DETERMINED. THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER REPLACING, ARRANGING WITH ABOVE MENTIONED COMPONENTS. THE INVESTIGATION IS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT IS DETERMINED NOT TO BE A NEW CONFIRMED QUALITY OR MANUFACTURING ISSUE AND THIS COMPLAINT WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW BATTERY ALARM WAS APPEARING ON THE SCREEN. PATIENT TRIED A FEW DIFFERENT OUTLETS AND EVEN REPOWERED THE MACHINE BUT THE ALARM WAS STILL APPEARING. IT WAS LATER DISCOVERED THAT THE PUMP WIRING WAS FRAYED. NO HARM OR DELAY IN TREATMENT TO PATIENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707442 ACTIVECARE +SFT SYSTEM SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. 63842242

    Patients

    Seq Age Sex Outcome Treatment
    1