BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3760676 · Received April 9, 2014

    Report

    Report Number
    1218950-2014-01960
    Event Type
    Death
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 17, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO ACQUIRE A PADS ECG WAVEFORM DURING A CARDIAC ARREST. THE INVOLVED PT DIED BUT THE CUSTOMER HAS STATED THAT THE DEVICE BEHAVIOR DID NOT IMPACT THE PT OUTCOME. THEY MONITORED THE PT VIA LEADS ECG. THE PT HAD AN UNWITNESSED CARDIAC ARREST AND WAS ASYSTOLIC DURING THE EVENT. THERE WAS NO DELAY IN TREATMENT AND THE RHYTHM WAS NOT SHOCKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212965 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death