BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 LT WT FIBER OPT SURG HELMET

    MDR report key: 5103432 · Received September 25, 2015

    Report

    Report Number
    0001811755-2015-03544
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 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

    THE DEVICE WAS SCRAPPED BY STRYKER.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE CORD OF THE DEVICE WAS OVERHEATING. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE CORD OF THE DEVICE WAS OVERHEATING. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634819 T5 LT WT FIBER OPT SURG HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1