BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 SURGICAL HELMET

    MDR report key: 4897902 · Received July 8, 2015

    Report

    Report Number
    0001811755-2015-02438
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 16, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SCRAPPED BY STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    442404 T5 SURGICAL HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO 13318

    Patients

    Seq Age Sex Outcome Treatment
    1