BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1983728 · Received February 3, 2011

    Report

    Report Number
    1218950-2011-00293
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING OP-CHECK WITH THIS DEFIBRILLATOR. THE DEFIBRILLATOR WAS RETURNED TO PHILIPS FOR EVALUATION. THE REPORTED SYMPTOM WAS DUPLICATED. REPLACEMENT OF THE THERAPY PCA RESOLVED THE SYMPTOM.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING OP-CHECK WITH THIS DEFIBRILLATOR.

    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