BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC

    MDR report key: 20915587 · Received December 11, 2024

    Report

    Report Number
    MW5163556
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Report Date
    December 9, 2024
    Manufacturer
    ZIMMER BIOMET/ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO USE ON A PATIENT, THE PULSAVAC IN THE RING STAND STARTED GOING OFF BY ITSELF. THE HANDPIECE AND BATTERY PACK BOTH GOT REALLY HOT. THERE WAS NO SMOKE AND IT WAS REMOVED FROM THE FIELD. REF #: 00-5150-482-00, LOT #: 78673223, EXP:07/23/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377011 PULSAVAC LAVAGE, JET FQH ZIMMER BIOMET/ZIMMER SURGICAL, INC. 78673223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other