BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEPAK 20 DEFIBRILLATOR / MONITOR

    MDR report key: 842873 · Received April 26, 2007

    Report

    Report Number
    3015876-2007-00092
    Event Type
    Other
    Date Received
    April 26, 2007
    Date of Event
    January 26, 2007
    Report Date
    April 23, 2007
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Removal / Correction Number
    FA-224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC INVESTIGATED THE REPORTED ISSUE AND DETERMINED THAT WITH DEVICES WITH OPERATING SYSTEM SOFTWARE VERSION 48 AND 52, A TIMING ERROR CAN OCCUR WHICH PREVENTS COMPLETION OF THE POWER-ON SEQUENCE, CAUSING THE DISPLAY TO TURN WHITE. A VOLUNTARY FIELD ACTION WAS INITIATED BY MEDTRONIC ON 04/23/2007 TO UPGRADE DEVICES WITH OPERATING SYSTEM SOFTWARE 48 AND 52 TO CORRECT THE ISSUE. WHILE THE DEVICES ARE BEING UPGRADED, MEDTRONIC RECOMMENDS TO CUSTOMERS TO TURN THE DEFIBRILLATOR POWER OFF AND BACK ON TO RESTORE NORMAL OPERATION IN THE EVENT OF A WHITE SCREEN CONDITION. MEDTRONIC NOTIFIED THE LOCAL FDA OFFICE OF THIS FIELD ACTION ON 04/23/2007.

    Description of Event or Problem · 1

    MEDTRONIC IS INVESTIGATING REPORTS THAT DEVICES WITH OPERATING SYSTEM VERSION 48 AND 52 CAN EXPERIENCE A "WHITE SCREEN" LOCK-UP CONDITION, WHEN THE MACHINE IS BEING POWERED ON. THIS CONDITION COULD CAUSE A DELAY IN THE DELIVERY OF A DEFIBRILLATING SHOCK, POSSIBLY RESULTING IN A FAILURE TO RESUSCITATE A PATIENT. THERE HAVE BEEN NO CONFIRMED OCCURRENCES DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR / MONITOR LDD MEDTRONIC EMERGENCY RESPONSE SYSTEMS 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR