BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK DEFIBRILLATOR

    MDR report key: 77375 · Received March 20, 1997

    Report

    Report Number
    MW1010985
    Event Type
    Malfunction
    Date Received
    March 20, 1997
    Date of Event
    March 7, 1997
    Report Date
    March 12, 1997
    Manufacturer
    PHYSION CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN ARREST. CPR IN PROGRESS AND CARDIAC MONITOR IN PLACE AND WORKING. WITHOUT WARNING, MONITOR SCREEN WENT BLANK. ONLY AFTER PRESSING RESTART BUTTON DID SCREEN REAPPEAR. SAME MONITOR REPORTED IN 1010867.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK DEFIBRILLATOR DEFIBRILLATOR LDD PHYSION CONTROL CORP. 9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other