BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1833970 · Received August 31, 2010

    Report

    Report Number
    1218950-2010-01448
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 3, 2010
    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 THAT THE PACER OUTPUT WAS OUT OF RANGE OR THERE WAS NO OUTPUT. THE PHILIPS RESPONSE CENTER STAFF LOCALIZED THE ISSUE TO A FAILED THERAPY PCA WITH THE CUSTOMER. A THERAPY PCA WAS ORDERED. AS OF 08/26/10, THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS DEVICE. WE ARE CONSIDERING THIS A THERAPY PCA MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACER OUTPUT WAS OUT OF RANGE OR THERE WAS NO OUTPUT.

    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