BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE-STAT

    MDR report key: 2591900 · Received May 22, 2012

    Report

    Report Number
    1821850-2012-00005
    Event Type
    Other
    Date Received
    May 22, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 22, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OWNER/USER INVESTIGATION INTO THE INCIDENT DETERMINED THAT THERE WAS NO PROBLEM WITH THE DEVICE BUT RATHER THE INCIDENT WAS CAUSED BY USER ERROR. THE DEVICE HAS BEEN USED SEVERAL TIMES SINCE THE EVENT DESCRIBED HERE WITHOUT A PROBLEM.

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED TO PROVIDE CARDIOPULMONARY RESUSCITATION ON A PT IN CARDIAC ARREST. THE PT CODED SEVERAL TIMES AND IT WAS REPORTED THAT THE UNIT WAS TURNED OFF AND WOULD NOT RESTART. THE DEVICE WAS REMOVED FROM THE PT AND MANUAL CPR CONTINUED. THE PT WAS NOT REVIVED. IT WAS STATED BY THE ICU TEAM THAT THE FAILURE OF THE DEVICE DID NOT AFFECT THE OUTCOME OF THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR