BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2856296 · Received December 4, 2012

    Report

    Report Number
    3015876-2012-00872
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE INTERNAL PADDLES ASSEMBLY IN QUESTION FROM THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE OPERATION OF THE DISCHARGE BUTTON WAS INTERMITTENT AND MOVEMENT OF THE CABLE NEAR THE HANDLE ALSO CAUSED INTERMITTENT OPERATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT SET OF INTERNAL PADDLES ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4): MODEL #: NA / CATALOG #: VLP12 / SERIAL #: NI.MODEL #: 20 / CATALOG #: 3202488 / SERIAL #: (B)(4).PMA / 510(K) #: K102972.(B)(4) SHOULD INDICATE PMA / 510(K) #: K063119.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISCHARGE BUTTON ON THE CUSTOMER'S INTERNAL PADDLES ASSEMBLY FOR THEIR DEVICE WAS NOT FUNCTIONING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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