BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 173083 · Received June 9, 1998

    Report

    Report Number
    3015876-1998-00305
    Event Type
    Malfunction
    Date Received
    June 9, 1998
    Report Date
    June 9, 1998
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION BY PHYSIO-CONTROL DETERMINED NO FAILURES IN EITHER PRODUCTION OR IN THE FIELD. PHYSIO-CONTROL WILL CONTINUE TO MONITOR THE FREQUENCY AND SEVERITY OF THE OCCURRENCE AND REPORT TO FDA AS REQUIRED. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.

    Description of Event or Problem · 1

    ENGINEERING TRIGGERED AN INVESTIGATION BASED UPON FAILURES OBSERVED DURING PRODUCT TESTING. NO PRODUCTION OR FIELD FAILURES HAVE OCCURRED. THE FAILURES INVOLVE AN INABILITY TO VIEW THE PUSH ANALYZE MENU. A FAILURE COULD HINDER THE ABILITY TO PERFORM PT ELECTROCARDIOGRAM ANALYSIS IN THE AED MODE OF OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR LDD PHYSIO-CONTROL CORP. 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA