BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2051883 · Received March 14, 2011

    Report

    Report Number
    1218950-2011-00679
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE DISPLAYED AN ERROR CODE AND WOULD NOT BECOME OPERATIONAL. THERE WAS NO PT INVOLVEMENT. THE LOCAL PHILIPS REP CONFIRMED THE INOPERABLE CONDITION AND RESOLVED THE CONDITION BY REPLACING THE POWER AND THERAPY PCAS. THE DEVICE THEN PASSED ALL TESTING AND WAS RETURNED TO SERVICE. BECAUSE MULTIPLE PARTS WERE REPLACED, THE SPECIFIC CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DISPLAYED AN ERROR CODE AND WOULD NOT BECOME OPERATIONAL. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1