BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2102338 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01408
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED MULTIPLE ISSUES WITH THE DEVICE INCLUDING A SHOCK EQUIPMENT AND PACER EQUIPMENT MALFUNCTION MESSAGE, AND NOT BEING ABLE TO CHARGE OR TURN THE UNIT OFF DURING OP CHECK. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE ISSUES WITH THE DEVICE INCLUDING A SHOCK EQUIPMENT AND PACER EQUIPMENT MALFUNCTION MESSAGE, AND NOT BEING ABLE TO CHARGE OR TURN THE UNIT OFF DURING OP CHECK.

    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