BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE-STAT

    MDR report key: 2803325 · Received October 16, 2012

    Report

    Report Number
    1821850-2012-00013
    Event Type
    Other
    Date Received
    October 16, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS NOT INITIATED BY THE USER, BUT WAS OBTAINED SECOND HAND DURING A SALES F/U CALL. FURTHER DISCUSSION WITH THE USER INDICATED THAT NO FAILURE OCCURRED; THE BACKBOARD STRAPS WERE NOT TIGHTENED PROPERLY WHICH CONTRIBUTED TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    DURING A RESUSCITATION ATTEMPT, IT WAS REPORTED THAT THE BOARD FOR THE DEVICE MOVED AROUND ON THE PT TORSO AND ALLOWED THE PT TO MOVE AROUND. THE LOOSE BOARD ALLOWED FOR THE COMPRESSION PAD TO MIGRATE AROUND THE PT'S CHEST. PAD WAS REPOSITIONED AND COMPRESSIONS CONTINUED. THE PT DID NOT SURVIVE. THE PARAMEDIC STATED THAT THE PROBLEM DID NOT AFFECT THE OUTCOME OF THE RESUSCITATION ATTEMPT IN ANY WAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR