BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART MRX

    MDR report key: 3010685 · Received March 13, 2013

    Report

    Report Number
    MW5029375
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHILLIPS MONITOR STOPPED WORKING WHILE HOOKING PT UP TO A 12-LEAD. PT WAS HAVING AN STEMI, AND WE WERE NOT ABLE TO READ THE MONITOR. MONITOR ALSO WOULDN'T PRINT OR DIAGNOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106174 PHILIPS HEARTSTART MRX MONITOR CARDIAC MHX

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other