BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 10737384 · Received October 26, 2020

    Report

    Report Number
    3002834373-2020-00003
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Product Code
    JOW
    PMA / PMN Number
    K101915
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE PRODUCT CODE: JOW. REPORTED ISSUE: UNIT HAD A CRACKED FRONT CASE. DEVICE EVALUATIONS RESULTS/INVESTIGATION FINDINGS: AS PER CALIBRATION SHEET, DEVICE FAILED TO TURN ON. FRONT CASE AND FACE LABEL CRACKED. POWER SOCKET BROKEN. POWER CORD CASING TORN. TIMING MOTOR NOT SWITCHING. TRANSDUCER FAILED - HIGH OUTPUT. COMPRESSOR FAILED REPLACED DAMAGED FRONT CASE WITH LABELS, AND POWER CORD, BROKEN POWER SOCKET AND DEFECTIVE TIMING MOTOR AND VALVE ASSEMBLY, MAIN PCB AND COMPRESSOR. PROBABLE CAUSE/ROOT CAUSE: 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 (CSFA): THE AVERAGE AGE OF THE FRONT CASE DURING REPLACEMENT IS 2.5 YEARS. CONCLUSION: 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 PER PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRACKED FRONT CASE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203243 VASOPRESS DIGITAL MINI PUMP TOURNIQUET, PNEUMATIC JOW COMPRESSION THERAPY CONCEPTS, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1