BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2802906 · Received October 24, 2012

    Report

    Report Number
    3015876-2012-00793
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE FAILURE OF THE THERAPY CONNECTOR ASSEMBLY. PHYSIO WILL REPLACE THE THERAPY CONNECTOR ASSEMBLY TO RESOLVE THE ISSUE. THE DEVICE WILL BE REPAIRED AND RETURNED TO THE CUSTOMER FOR USE AFTER CONFIRMATION OF PROPER OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY FAILED THE USER TEST BY FAILING TO DETECT THE TEST PLUG. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT THE DEVICE INTERMITTENTLY FAILED TO DETECT THE THERAPY CABLE CONNECTION WHEN EITHER THE CONNECTOR OR CABLE WAS WIGGLED. THE DEVICE WOULD NOT BE ABLE TO PROVIDED DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. 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