BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STA

    MDR report key: 2621601 · Received June 12, 2012

    Report

    Report Number
    1821850-2012-00006
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 10, 2012
    Report Date
    June 12, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT YET BEEN EVALUATED. IT WAS SENT TO US BUT HAS NOT YET ARRIVED. FOLLOW UP INFO WILL BE SENT WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE USER WAS ATTEMPTING TO RESUSCITATE A PT AND REPORTED THAT AFTER TWO MINUTES OF USE THE COMPRESSION DEPTH OF THE DEVICE SPONTANEOUSLY INCREASED. THE DEVICE WAS REMOVED FROM THE PT AND MANUAL CPR WAS CONTINUED. THE PT WAS REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-STA CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR