BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 4268076 · Received November 12, 2014

    Report

    Report Number
    1218950-2014-06831
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Report Date
    October 27, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE HAD AN ECG EQUIP MALFUNCTION INOP MESSAGE AND ECG BIAS ERRORS IN THE STATUS LOG. THERE WAS NO REPORTED PT INVOLVEMENT OR NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729504 HEARTSTART MRX MJK PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1