BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL PUMP

    MDR report key: 9592051 · Received January 15, 2020

    Report

    Report Number
    0001526350-2020-00066
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    July 20, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K061814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). DEVICE PRODUCT CODE: JOW. UDI NO.:(B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE VP500D VASOPRESS PUMP WITH SERIAL NUMBER (B)(4) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. PRODUCT REVIEW OF THE VP500D VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON AUGUST 09, 2019 REVEALED THAT THE POWER CORD WAS DAMAGED. THE POWER CORD WIRES WERE EXPOSED PER THE VERBAL COMMUNICATION WITH THE TECHNICIAN. REPAIR OF THE VP500D VASOPRESS PUMP WAS NOT PERFORMED BY ZIMMER BIOMET SURGICAL DUE TO THE DEVICE BEING SCRAPPED AFTER PRODUCT EVALUATION. THE REPORTED EVENT "THE DEVICE WILL NOT POWER ON" WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE DEVICE WOULD NOT BE ABLE TO POWER ON WITH A CUT POWER CORD. A DEFINITIVE ROOT CAUSE OF THE DEVICE NOT POWERING ON COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE REPORTED EVENT WAS NOT CONFIRMED AS THERE WAS NO POWER ISSUE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. 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 DEVICE WILL NOT POWER ON. DURING EVALUATION, IT WAS DISCOVERED THAT THERE WAS EXPOSED WIRING ON THE DEVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57332 VASOPRESS DIGITAL PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1