BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 2591820 · Received May 22, 2012

    Report

    Report Number
    1821850-2012-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2012
    Date of Event
    April 11, 2012
    Report Date
    May 22, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER AN EXTENSIVE EVAL OF THIS DEVICE, THE COMPLAINT COULD NOT BE CONFIRMED. BOTH FUNCTIONAL AND SIMULATION TESTS WERE CONDUCTED OVER SEVERAL DAYS. THE REPORTED PROBLEM COULD NOT BE DUPLICATED AND NO DEVIATION FROM THE DEVICE DESIGN SPECS WERE FOUND. EVAL SUMMARY: UNIT WAS RECEIVED IN GOOD CONDITION. THE UNIT WAS SET UP ON OUR STANDARD TEST/SIMULATION FIXTURE TO CONFIRM THE REPORTED PROBLEM. THE UNIT RAN TO IT'S SPEC THE REPORTED PROBLEM COULD NOT BE DUPLICATED. AT THAT POINT LONG TERM TESTING WAS INITIATED. THE UNIT WAS SET UP AND RUN AT VARIOUS TIMES OVER SEVERAL DAYS ALTERNATING BETWEEN CCV AND 30:2 MODES: (B)(6) 2012 - 7:30AM TO 8:04AM, 9:00AM TO 9:30AM, 9:45AM TO 10:15AM, 11:00AM TO 11:30AM, 12:30PM TO 2:00PM, 2:15PM TO 3:00PM. ON (B)(6) 2012: 12:30PM TO 1:30PM - 30:2 MODE, 1:30PM TO 2:30PM - CCV MODE. ON 5/10/2012 - 2:00PM TO 3:30PM. DURING ALL OF THE TESTING THE UNIT WAS RUNNING TO IT'S SPECS. AT NO TIME WERE THERE ANY DEVICE FAILURES OR DEVIATIONS FROM FACTORY SPECS.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PT REQUIRING CARDIOPULMONARY RESUSCITATION IN A HOSP SETTING. IT WAS REPORTED THAT AFTER 10 MINUTES OF USE THE DEVICE STOPPED FOR 1 SECOND AND THEN STARTED WORKING AGAIN. AFTER ANOTHER 20 MINUTES OF USE THE DEVICE STOPPED. IT WAS REMOVED FROM THE PT AND MANUAL CPR CONTINUED. THE PT DID NOT SURVIVE. IT WAS THE OPINION OF THE OPERATOR THAT THE PROBLEM WITH THE DEVICE DID NOT AFFECT THE PT OUTCOME.

    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 40 YR