BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3003424 · Received February 8, 2013

    Report

    Report Number
    1218950-2013-00453
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WOULD INTERMITTENTLY FAIL TO POWER UP, UNEXPECTEDLY RESTART, AND DISPLAY THE MESSAGE "ALL SETTINGS HAVE BEEN RESET TO DEFAULT VALUES." THE CUSTOMER REPORTED THESE SYMPTOMS PRESENTED DURING THEIR DAILY TEST (USER INITIATED OPERATIONAL CHECK). THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY THE PHILIPS EU BENCH AND THE STATED PROBLEM WAS CONFIRMED. THE EU BENCH FOUND THE CAUSE OF THESE FAILURE SYMPTOMS TO HAVE BEEN THE INTERNAL MEMORY CARD. PHILIPS EU BENCH REPLACED THE INTERNAL MEMORY CARD WHICH RESOLVED THE CONDITIONS OF THIS MALFUNCTION. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. THIS WAS AN INTERNAL MEMORY (DATA) CARD MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD INTERMITTENTLY FAIL TO POWER UP, UNEXPECTEDLY RESTART, AND DISPLAY THE MESSAGE :ALL SETTINGS HAVE BEEN RESTART, AND DISPLAY THE MESSAGE "AL SETTINGS HAVE BEEN RESET TO DEFAULT VALUES." THE CUSTOMER REPORTED THESE SYMPTOMS PRESENTED DURING THEIR DAILY TEST (USER INITIATED OPERATIONAL CHECK). THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55232 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1