BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 3751922 · Received April 15, 2014

    Report

    Report Number
    1821850-2014-00003
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MICHIGAN INSTRUMENTS, INC
    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

    A THOROUGH INVESTIGATION WAS INITIATED AND COMPLETED ON THIS UNIT. BOTH MECHANICAL AND FUNCTIONAL TESTING WAS DONE INCLUDING LONG TERM OPERATION TESTING. THE COMPLAINT WAS CONFIRMED WHEN TESTED. IT WAS FOUND THAT THE CONTROL PANEL WAS NOT FUNCTIONING. OUR INVESTIGATION FOUND THAT THE UNIT HAD BEEN MODIFIED BY THE USER. THE MODIFICATION ALLOWED REVERSED POLARITY IN THE CONTROL PANEL WHICH ULTIMATELY SHORTED THE UNIT CAUSING A FAILURE. THE UNIT WILL RECEIVE THE RECOMMENDED FACTORY SERVICE AND BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT AFTER 15 MINUTES THE DEVICE DEVELOPED AN UNKNOWN PROBLEM (THE EXACT PROBLEM HAS NOT BEEN REPORTED BY THE CUSTOMER). THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS CONTINUED. WHEN THE DEVICE WAS TESTED BY THE DISTRIBUTOR, IT WAS FOUND THAT THE CONTROL PANEL WOULD NOT FUNCTION. THE PATIENT WAS NOT REVIVED. IT WAS REPORTED THAT THE FAILURE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229036 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, INC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR