BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 4291466 · Received December 2, 2014

    Report

    Report Number
    1821850-2014-00007
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 10, 2014
    Report Date
    December 2, 2014
    Manufacturer
    MICHIGAN INSTRUMENTS, INC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW BASE WAS SUPPLIED TO THE USER. THE BASE DESIGN FOR THIS DEVICE HAS BEEN IN USE CONTINUALLY FOR THE PAST SIXTEEN YEARS. A BROKEN BASE IS A VERY UNUSUAL OCCURRENCE BUT HAS OCCURED SEVERAL TIMES WITH THIS PARTICULAR EMS SERVICE. AS A RESULT REPRESENTATIVES WERE SENT TO MEET WITH THESE USERS TO TRY TO DETERMINE IF THE DEVICE IS BEING USED AND HANDLED PROPERLY. EXTENSIVE TESTING WAS ALSO DONE ON THE BASE TO DETERMINE IF SOME FACTOR, SUCH AS MATERIALS OR MANUFACTURING PROCESS HAS CHANGED AND IS CONTRIBUTING TO THIS PROBLEM. TESTING AND EVALUATION CONCLUDED THAT ALTHOUGH POSSIBLE TO BREAK A BASE, IT REQUIRES FORCES THAT SHOULD NOT BE PRESENT DURING NORMAL USE. IN ADDITION, WE HAVE STARTED THE PROCESS OF INCREASING THE STRENGTH OF THE BASE BY USING A STRONGER MATERIAL AND A MOLD CHANGE.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PATIENT IN CARDIAC ARREST. BEFORE THE PROPER COMPRESSION DEPTH WAS ATTAINED, THE BASE PLATE OF THE DEVICE MADE A CRACKING NOISE AND BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS CONTINUED. THE PATIENT WAS NOT REVIVED. IT WAS REPORTED BY (B)(6) THAT THE FAILURE OF THE DEVICE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778843 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, INC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR