BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 POWER PACK

    MDR report key: 5004496 · Received August 14, 2015

    Report

    Report Number
    0001811755-2015-02931
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SCRAPPED BY STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A MEDICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539441 T4 POWER PACK HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO 14258

    Patients

    Seq Age Sex Outcome Treatment
    1