BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART MRX

    MDR report key: 2579758 · Received May 14, 2012

    Report

    Report Number
    MW5025410
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEM
    Product Code
    MJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHILIPS MRX'S MONITOR IN 12 LEAD ECG MODE SHOWS ALL 12 LEAD ON THE MONITOR, BUT FAILED TO ACQUIRE 12 IN STANDARD DIAGNOSTICS MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS HEARTSTART MRX MRX M3539A MJK PHILIPS MEDICAL SYSTEM M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR