BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2113630 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01439
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE AC POWER MODULE CONNECTOR SEPARATED AND THE WIRES BROKE. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER WAS SENT A REPLACEMENT AC POWER MODULE TO RESOLVE THE FAILURE. THE MODULE WAS NOT RETURNED FOR EVALUATION. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE CONNECTOR SEPARATED AND THE WIRES BROKE. THERE WAS NO REPORTED 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