BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 SURGICAL HELMET

    MDR report key: 3232564 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01668
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE DUPLICATED. NO PROBLEM WAS FOUND WITH THE HELMET THAT RELATED TO THE REPORTED EVENT. THE HELMET IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE PHYSICIAN'S ASSISTANT WAS FEELING HEAT WHERE THE BATTERY ATTACHES TO THE HELMET, HOWEVER IT WAS REPORTED THAT THERE WAS NO PHYSICAL BURN. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY AND NO MEDICAL INTERVENTION WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE PHYSICIAN'S ASSISTANT WAS FEELING HEAT WHERE THE BATTERY ATTACHES TO THE HELMET, HOWEVER IT WAS REPORTED THAT THERE WAS NO PHYSICAL BURN. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY AND NO MEDICAL INTERVENTION WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336213 T5 SURGICAL HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO 12062

    Patients

    Seq Age Sex Outcome Treatment
    1