BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 3935382 · Received July 15, 2014

    Report

    Report Number
    1821850-2014-00004
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 22, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MICHIGAN INSTRUMENTS, INC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION WAS INITIATED AND COMPLETED ON THIS UNIT. BOTH MECHANICAL AND FUNTIONAL TESTING WAS DONE. THE COMPLAINT WAS CONFIRMED WHEN TESTED. IT WAS FOUND THAT THE VENTILATION KNOB HAD BECOME LOOSE WITH HINDERED THE ABILITY TO ADJUST THE VENTILATION VOLUME. THE KNOB WAS TIGHTENED TO SPECIFICATIONS AND IN SUBSEQUENT TESTING THE UNIT PERFORMED TO ITS' SPECIFICATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT THE NURSE PRACTITIONER WAS NOT ABLE TO ADJUST THE VENTILATION VOLUME ON THE DEVICE. THE DEVICE WAS NOT REMOVED FROM THE PATIENT AND WAS USED TO PERFORM CHEST COMPRESSIONS FOR 37 MINUTES. VENTILATION WAS DONE MANUALLY WITH A RESUSCITATION BAG. THE PATIENT WAS NOT REVIVED. IT WAS REPORTED THAT THE DEVICE PERFORMED CHEST COMPRESSIONS AS IT WAS DESIGNED TO DO AND THE FAILURE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413884 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, INC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1