BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 2621602 · Received June 12, 2012

    Report

    Report Number
    1821850-2012-00007
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 12, 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 SPECIFICATIONS WERE FOUND. THIS UNIT WAS RECEIVED IN FAIR CONDITION. THE DOME WAS STARTING TO GET DARK AND THE MASSAGER PAD WAS BEGINNING TO SPLIT. THIS TYPICALLY SIGNIFIES HEAVY USE WITH A SIGNIFICANT NUMBER OF CYCLES. THE UNIT WAS SET UP ON OUR STANDARD TEST/ SIMULATION FIXTURE TO CONFIRM THE REPORTED PROBLEM. THE UNIT RAN TO ITS SPECIFICATION. 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)(4) 2012 ¿ 12:48, TO 1:18PM, CCV MODE; 1:18 TO 2:00PM, 30:2 MODE. ON (B)(4) 2012 ¿ 2:15PM TO 3:00PM, CCV MODE; 3:00PM TO 3:30PM, 30:2 MODE. ON (B)(4) 2012 ¿ 7:30AM TO 8:30AM, 30:2 MODE; 8:30AM TO 9:30AM, CCV MODE. DURING ALL OF THE TESTING THE UNIT WAS RUNNING TO IT'S SPECIFICATIONS. AT NO TIME WERE THERE ANY DEVICE FAILURES OR DEVIATIONS FROM FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED TO PROVIDE RESPIRATORY AND CIRCULATORY SUPPORT TO A PT IN CARDIAC ARREST. IT WAS REPORTED THAT AFTER TWENTY MINUTES OF USE, THE DEVICE STOPPED AT A COMPRESSION DEPTH OF 3CM. THE UNIT WAS REMOVED FROM THE PT AND MANUAL CPR WAS CONTINUED. THE PT WAS REVIVED.

    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 68 YR