BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS PUMP

    MDR report key: 9460661 · Received December 12, 2019

    Report

    Report Number
    3002834373-2019-00009
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Product Code
    JOW
    PMA / PMN Number
    K991038
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. PRO CODE - JOW. UDI - (B)(4). DEVICE EVALUATIONS RESULTS/INVESTIGATION FINDINGS: POWER CORD WAS DAMAGED ( CASING WAS TORN AND GROUND WIRE WAS CUT). PROBABLE CAUSE/ROOT CAUSE: 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. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME. 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 WAS NOT WORKING, AND THE POWER CORD HAD EXPOSED WIRES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258183 VASOPRESS PUMP SLEEVE, LIMB, COMPRESSIBLE JOW COMPRESSION THERAPY CONCEPTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1