BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 385060 · Received March 21, 2002

    Report

    Report Number
    3015876-2002-00107
    Event Type
    Malfunction
    Date Received
    March 21, 2002
    Report Date
    February 19, 2002
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE FAILED DURING FACILITY BIOMEDICAL DEPARTMENT TESTING. ALLEGEDLY, THE DEFIBRILLATOR WOULD NOT CHARGE OR RECOGNIZE ATTACHMENT OF STANDARD PADDLES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA