BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 HELMET POWER PACK

    MDR report key: 7108660 · Received December 12, 2017

    Report

    Report Number
    0001811755-2017-02430
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    June 1, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE EVALUATED THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY, THE DEVICE WAS OVERHEATING BUT DID NOT CATCH FIRE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY, THE DEVICE WAS OVERHEATING BUT DID NOT CATCH FIRE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886817 T4 HELMET POWER PACK HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO 17017

    Patients

    Seq Age Sex Outcome Treatment
    1