BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVECARE DVT SYSTEM (JP)

    MDR report key: 8884829 · Received August 12, 2019

    Report

    Report Number
    0001526350-2019-00643
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    April 22, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K140755
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE - JOW. DHR/REPAIR HISTORY REVIEW: THE DEVICE HISTORY RECORD (DHR) OF ACTIVECARE DVT 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 THIS DEVICE IS NOT REPAIRED PREVIOUSLY FOR A COMPLAINT WITH CURRENT SERIAL NUMBER (B)(4). TECHNICAL REVIEW AND PHYSICAL EVALUATION: ON (B)(6) 2019, IT WAS REPORTED THAT THE DEVICE HAD NO INFLATION ON BOTH SLEEVES. WHILE EVALUATING THE DEVICE SERVICE TECHNICIAN CONFIRMED THE REPORTED EVENT BECAUSE THE DEVICE SOLENOID VALVES ARE LOOSE (SHIFTED TO LEFT). ALSO NOTED BELOW MENTIONED ERRORS. POWER SUPPLY AND EXTENSION TUBES WERE NOT RETURNED ALONG WITH THE DEVICE. CARRYING STRAP WAS DEFORMED. ACTIVECARE POWER SUPPLY ONLY LABEL MISSING. BATTERY HAD REACHED TO END OF LIFE (EOL) STAGE. ERROR MESSAGE APPEARS IN CALF-CALF MODE BECAUSE THE SOLENOID VALVE ARE LOOSE. OVP WIRING (FRAYING) WAS DAMAGED, NEOPRENE SHEETS ARE MISSING. THE DEVICE HAD OLD PCA VERSION. SERVICE TECHNICIAN THEN REPLACED BELOW MENTIONED COMPONENTS FOR THE DEVICE AND CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE DEVICE WAS TESTED, INSPECTED AS PER INVESTIGATION RESULTS AND REPAIR. CARRYING STRAP (A504A155010), BUZZER PAD (401A000101), PCB PU (401A000501), PCA GEN A (506B001810), BATTERY PACK (503A200002), MANIFOLD ASSEMBLY (504A000202), SQUARE WARRANTY SEAL (350W000102), RUBBER FLOOR (321A000101), ACTIVECARE PS ONLY LABEL (350W000201), OVER VOLTAGE PROTECTION GEN A (503A500001). PROBABLE CAUSE/ROOT CAUSE: THE CAUSE OF THE REPORTED EVENT WAS DUE TO SOLENOID VALVES. IF DEVICE SOLENOID VALVE IS MALFUNCTIONED OR ARE DAMAGED, AIR WILL LEAK WHICH RESULTS IN SLOW PRESSURE ELEVATION. A LESS EFFECTIVE TREATMENT MAY RESULT DUE TO THE INFLATION AND DEFLATION SEQUENCES BEING INTERRUPTED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER REPLACING THE DEVICE WAS REPLACED WITH ABOVE MENTIONED COMPONENTS. THE INVESTIGATION IS BASED ON THE INFORMATION THAT IS PROVIDED INITIALLY AND ANY INFORMATION THAT IS 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 PER COMPLAINT TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NO INFLATION ON BOTH SLEEVES. DURING THE INVESTIGATION, IT WAS DISCOVERED THAT OVP WIRING WAS FRAYED/DAMAGED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677951 ACTIVECARE DVT SYSTEM (JP) SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1