BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1163405 · Received September 10, 2008

    Report

    Report Number
    1218950-2008-00491
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION TO DATE HAS SHOWN THAT THERE WAS A THERAPY PCA FAILURE. A FOLLOW UP REPORT WILL BE SUBMITTED, AFTER PHILIPS OBTAINS MORE INFO CONCERNING THE EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1