BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 7970136 · Received October 16, 2018

    Report

    Report Number
    1821850-2018-00002
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 8, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY THE DISTRIBUTOR (TRAINED AND CERTIFIED BY THE MANUFACTURER) WHO CONFIRMED THE CUSTOMER'S INITIAL COMPLAINT. THEY DETERMINED THE MALFUNCTION OF THE DEVICE WAS ISOLATED TO THE IGOR VALVE, (A PNEUMATIC COMPONENT DRIVEN BY ELECTRONIC SIGNALS). THE ELECTRONIC WIRE CONNECTOR TO THE IGOR WAS RE-POSITIONED, SECURED AND THE DEVICE WAS RE-TESTED TO ALL FINAL TEST PROCEDURES. THE DISTRIBUTOR CONFIRMED THE DEVICE PASSED ALL FINAL TESTING AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED ON A PATIENT TO PERFORM CPR. IT WAS REPORTED THE DEVICE STOPPED COMPRESSIONS AFTER 30 MINUTES OF OPERATION. PATIENT WAS NOT REVIVED. IT WAS THE OPERATOR'S OPINION THAT THE PROBLEM WITH THE DEVICE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812402 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR