BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9719765 · Received February 18, 2020

    Report

    Report Number
    3002834373-2020-00002
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Report Date
    February 18, 2020
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Product Code
    JOW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE PRODUCT CODE: JOW UDI #: (B)(4). PMA/510(K) NUMBER: K101915 & K061814. THERE WERE DAMAGES TO THE POWER CORD, REAR HOUSING, FACE LABEL, AND HOOK. THE DEVICE WOULD NOT POWER ON BECAUSE THE POWER SUPPLY HAD NO OUTPUT VOLTAGE. REPLACED POWER CORD, REAR HOUSING WITH LABELS, FACE LABEL, HOOK, AND POWER SUPPLY. THE DAMAGE TO THE FRONT CASE, BACK CASE AND/OR HOSE SIDE PANEL COULD BE CAUSED BY DAMAGE DURING TRANSPORT, DROPPING OF THE DEVICE, THE PUMP BEING CRUSHED WHILE HANGING FROM THE BEDSIDE OR FROM GENERAL HANDING OF THE PRODUCT. THE CASE AND HOSE CONNECTOR PANEL ARE MADE FROM FLAME RETARDANT POLYMER. THE COMPONENTS ARE DIFFICULT TO DAMAGE IF USED AS INTENDED, MAKING IT UNLIKELY THAT THE CASE AND/OR HOSE SIDE PANEL FAILED DURING NORMAL USE. FOR VP500DM (CSBA): THE AVERAGE AGE OF THE BACK CASE DURING REPLACEMENT IS 2.2 YEARS. DAMAGE TO THE POWER CORD CAN OCCUR BY THE CORD/PLUG MOLD BEING RUN OVER BY WHEELED EQUIPMENT OR BY THE CORD BEING PULLED FROM THE WALL OUTLET INADVERTENTLY. IN SOME CASES DAMAGE TO THE WIRE COVERINGS AND INSULATION MAY EXPOSE THE WIRES OF THE CORD WHEN EXCESSIVE FORCE IS APPLIED IN A CLINICAL SETTING. UNDER NORMAL CONDITIONS THE POWER CORD AND PLUG MOLD ARE NOT LIKELY TO BECOME DAMAGED. FOR VP500DM: THE AVERAGE AGE OF THE POWER CORD DURING REPLACEMENT IS 2.5 YEARS. THE FAILURE RATE FOR THE POWER CORD IS 0.007%. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS IS A WELL-KNOWN FAILURE MODE, WITH NO ALLEGATIONS OF HARM OR INJURY. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD EXPOSED CORDS AND THE CASE WAS BROKEN. THERE WAS NO PATIENT IMPACT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187435 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW COMPRESSION THERAPY CONCEPTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1