BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9582810 · Received January 13, 2020

    Report

    Report Number
    0001526350-2020-00055
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Report Date
    January 13, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K101915
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: JOW. (B)(4). COULD NOT CONFIRM THE ALARM ISSUE. REPLACED THE DAMAGED POWER CORD AND FACE LABEL. THE REPORTED EVENT, "CP/OP" IS NOT CONFIRMED AND "POWER CORD DAMAGE AND OPEN WIRES" ARE CONFIRMED. THE REPORTED EVENT "CP/OP" WAS NOT CONFIRMED SINCE THE DEVICE FUNCTIONED AS INTENDED DURING PRODUCT REVIEW; HENCE, A ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. 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 (B)(4)%. 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 THERE WERE EXPOSED/FRAYED WIRES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47551 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1