BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK COMMUNICATION UNIT FOR ENT AUTOREGISTRATION MASK

    MDR report key: 2974320 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00356
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K002732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION RESULTS IT WAS EVIDENT THAT SEVERAL PINS OF THE COMMUNICATION UNIT WERE BROKEN/STUCK.

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MASK COMMUNICATION UNIT CAUSE A 60 MINUTES DELAY BECAUSE IT STOPPED WORKING IN THE MIDDLE OF A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; NO CLINICAL SIGNIFICANCE WAS ATTRIBUTED TO THE 60 MINUTE DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MASK COMMUNICATION UNIT CAUSE A 60 MINUTES DELAY BECAUSE IT STOPPED WORKING IN THE MIDDLE OF A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; NO CLINICAL SIGNIFICANCE WAS ATTRIBUTED TO THE 60 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77732 MASK COMMUNICATION UNIT FOR ENT AUTOREGISTRATION MASK STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1