BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2051875 · Received March 14, 2011

    Report

    Report Number
    1218950-2011-00684
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    January 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A CHARGE BUTTON TEST FAILURE DURING OP-CHECK. THERE WAS NO PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND FOUND THE DEVICE FAILED TO CHARGE FOR DEFIBRILLATION. THE THERAPY CAPACITOR WAS FOUND TO BE THE CAUSE OF THE FAILURE AND REPLACED. THE DEVICE PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHARGE BUTTON TEST FAILURE DURING OP-CHECK. 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