BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1771892 · Received July 22, 2010

    Report

    Report Number
    1218950-2010-01190
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Report Date
    June 24, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED, THE DISPLAY BECAME BLANK. THE UNIT WAS EVALUATED BY A PHILIPS REPRESENTATIVE. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE WE COULD NOT DUPLICATE THE SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE DISPLAY BECAME BLANK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1