BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2150345 · Received June 7, 2011

    Report

    Report Number
    1218950-2011-01606
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Report Date
    May 10, 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 THAT THE UNIT IS NOT CHARGING FOR DELIVERY OF DEFIB THERAPY. THE UNIT WAS EVALUATED AT PHILIPS AND THE REPORTED SYMPTOM WAS VERIFIED. THE POWER PCA WAS REPLACED WHICH RESOLVED THE REPORTED ISSUE. THE UNIT PASSED TESTING AND WAS RETURNED TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT IS NOT CHARGING FOR DELIVERY OF DEFIB THERAPY.

    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