BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 4964223 · Received August 4, 2015

    Report

    Report Number
    1821850-2015-00006
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MICHIGAN INSTRUMENTS, INC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION WAS INITIATED AND COMPLETED ON THIS UNIT. BOTH MECHANICAL, FUNCTIONAL AND LONG TERM TESTING WAS DONE. THE COMPLAINT COULD NOT BE CONFIRMED WHEN TESTED. THE DEVICE OPERATED WITHIN ALL OF ITS' SPECIFICATIONS. WE SUSPECT THAT THE PROBLEM WAS RELATED TO THE OXYGEN SUPPLY, EITHER THE USE OF A REGULATOR WITH INADEQUATE FLOW OR SOME OTHER INTERRUPTION IN THE SUPPLY. UNIT WAS RETURNED TO THE OWNER.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT WHEN ATTEMPTING TO USE THE DEVICE IT WOULD NOT COMPRESS TO THE 5CM DEPTH WITH THE CHEST DEPTH KNOB TURNED ALL THE WAY UP.. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS CONTINUED. THE PATIENT WAS NOT REVIVED. IT WAS REPORTED BY THE USER 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
    510687 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, INC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR