BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 9078616 · Received September 17, 2019

    Report

    Report Number
    1821850-2019-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    May 6, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    AFTER 10MINUTES, LIFE STAT STOPPED WORKING AND CHEST COMPRESSIONS WERE IMMEDIATELY STARTED (MANUALLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874054 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR