BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2803026 · Received October 24, 2012

    Report

    Report Number
    3015876-2012-00794
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND THE THERAPY CABLE AND THERAPY CONNECTOR PART NUMBER INFORMATION. FOLLOW UP WITH THE REPORTER CONFIRMED THAT THE CUSTOMER REPLACED THE DEVICE THERAPY CONNECTOR AND PURCHASED A REPLACEMENT THERAPY CABLE TO RESOLVE THE ISSUE. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE AFTER CONFIRMATION OF PROPER OPERATION. THE REMOVED ASSEMBLIES WERE NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS. HENCE, FURTHER CAUSE OF THE REPORTED ISSUE IS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE THERAPY CABLE PINS BROKE OFF INSIDE THE MATING CONNECTOR. THE DEVICE COULD NOT POSSIBLY CONNECT TO A THERAPY CABLE AND PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1