BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3889069 · Received May 21, 2014

    Report

    Report Number
    1218950-2014-02815
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 27, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PARAMEDIC

    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 CONTACTED PHILIPS HEALTHCARE TO REPORT THAT, DURING TRANSPORT OF A PATIENT, PACING CAPTURE WAS LOST. THE INVOLVED PARAMEDIC HAS STATED THAT THE DEVICE BEHAVIOR DID NOT IMPACT THE PATIENT. THE PATIENT'S VITAL SIGNS REMAINED STABLE WILE THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR TO CONTINUE TREATMENT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301795 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1