BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS 2

    MDR report key: 1962602 · Received January 12, 2011

    Report

    Report Number
    MW5018979
    Event Type
    Death
    Date Received
    January 12, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 5, 2011
    Manufacturer
    JOLIFE
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010, WE PURCHASED THREE LUCAS 2 CHEST COMPRESSION DEVICES FROM PHYSIO-CONTROL. WITHIN A TWO WEEK TIME FRAME, WE BEGAN TO HAVE FAILURES ON ONE OF OUR UNITS. PHYSIO-CONTROL WAS CONTACTED AND THEY REPLACED THAT UNIT. APPROXIMATELY TWO WEEKS LATER, THE OTHER TWO UNITS FAILED, BOTH THESE UNITS WERE ALSO REPLACED BY PHYSIO-CONTROL AND A LOANER UNIT WAS GIVEN TO US TO HOLD ONTO IN THE EVENT ANOTHER UNIT WENT DOWN. IN (B)(6), WE HAD ANOTHER UNIT FAILURE AND WE PUT THE LOANER UNIT INTO USE. THE FOLLOWING WEEK, THE LOANER UNIT WENT DOWN AND THEN ON (B)(6) 2010, ONE OF THE NEW UNITS WENT DOWN. ALL THESE ISSUES ARE THE RESULT OF THE BATTERY PINS STICKING IN THE UNIT AND NOT MAKING CONTACT WITH THE BATTERY. I WAS INFORMED BY PHYSIO-CONTROL THAT THEY HAD REPORTED THIS TO THE FDA AND WHEN I REQUESTED VERIFICATION OF THIS REPORT I WAS TOLD THAT THE "STOP SHIPMENT OF ANY FURTHER UNITS" WAS VOLUNTARY BY (B)(6). ALL THESE FAILURES OCCURRED ON FULL ARREST PTS WHO MAY OR MAY NOT HAVE BEEN ABLE TO BE REVIVED, BUT ALL PTS DID DIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUCAS 2 LUCAS 2 CHEST COMPRESSION DEVICE DRM JOLIFE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death