BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3810153 · Received February 4, 2014

    Report

    Report Number
    1218950-2014-00523
    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, DISPLAYED PAP (PULMONARY ARTERY), ABP (ARTERIAL BLOOD PRESSURE), AND TEMP EQUIPMENT MALFUNCTIONS. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73634 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1