BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3982583 · Received June 23, 2014

    Report

    Report Number
    1218950-2014-03617
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX DEFIBRILLATOR DID NOT CHARGE OR SHOCK DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366787 HEARTSTART MRX -EMS DEFIBRILLATOR MJK PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1