BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-SAT

    MDR report key: 2597688 · Received May 16, 2012

    Report

    Report Number
    1821850-2012-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    March 13, 2012
    Report Date
    May 15, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARM LOCK WAS REPLACED BY THE DISTRIBUTOR AND THE UNIT RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IN THE HOSP, DURING AN ATTEMPT TO PROVIDE CPR TO A HEART ATTACK VICTIM, IT WAS FOUND THAT THE ARM LOCK WAS BROKEN. THIS PREVENTED THE ARM FROM BEING LOCKED INTO POSITION ON THE COLUMN. THE DEVICE WAS REMOVED FROM THE PT, MANUAL CPR WAS APPLIED, AND THE PT WAS REVIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR