BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3810094 · Received February 4, 2014

    Report

    Report Number
    1218950-2014-00522
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Report Date
    January 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    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

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX, A STANDBY UNIT LOCATED IN THE SITES STANDBY CLOSET, HAD A RED X AND BEEPING WITH A RUNT TIME MAIN SOFTWARE MESSAGE. UPON NOTING THE ERROR MESSAGE, THE CUSTOMER WAS UNABLE TO TURN THE UNIT ON. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73479 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1