BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START MRX

    MDR report key: 888708 · Received September 21, 2006

    Report

    Report Number
    1218950-2006-00314
    Event Type
    Malfunction
    Date Received
    September 21, 2006
    Report Date
    August 23, 2006
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT DUPLICATE THE CUSTOMER'S REPORTED ENERGY SELECTION PROBLEM. THE CUSTOMER'S REPORTED SYMPTOMS ARE CONSISTENT WITH AN ENERGY SELECTION DEVICE MALFUNCTION. THE TESTING AT PHILIPS OF THE RETURNED UNIT IS CONSISTENT WITH THE ISSUE RESOLVING ITSELF DURING SHIPPING. AFTER PASSING ALL NEEDED TESTS, THE UNIT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAD A PROBLEM WITH THE ENERGY SELECT SWITCH. THE UNIT WAS SELECTING AN ENERGY DIFFERENT FROM THE ONE INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA