BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2112430 · Received May 23, 2011

    Report

    Report Number
    1218950-2011-01443
    Event Type
    Death
    Date Received
    May 23, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING A PT EVENT AN ETCO2 READING COULD NOT BE OBTAINED AND THE USERS ONLY SAW A "?" MARK FOR A NUMERIC READING. THE PT WAS PRONOUNCED IN THE FIELD. THERE WAS NO REPORT THAT THE DEVICE BEHAVIOR IMPACTED THE PT OUTCOME. THE ETCO2 FUNCTION DOES NOT IMPACT THE DELIVERY OF DEFIBRILLATION OR PACING. THIS MALFUNCTION IS BEING REPORTED DUE TO THE PT'S OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PT EVENT AN ETCO2 READING COULD NOT BE OBTAINED AND THE USERS ONLY SAW A "?" MARK FOR A NUMERIC READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death