BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2823153 · Received November 7, 2012

    Report

    Report Number
    3015876-2012-00830
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND PART NUMBER INFORMATION. THE BIOMED DISASSEMBLED THE DEVICE AND OBSERVED DAMAGE TO THE THERAPY PCB ASSEMBLY. THE CUSTOMER ELECTED TO PURCHASE A REPLACEMENT DEFIBRILLATOR INSTEAD OF REPAIR. THE DEVICE WAS REMOVED FROM SERVICE. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS OR REPAIR. THEREFORE, A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING, THE CUSTOMER BIOMED REPORTED THAT THE DEVICE STARTED TO PRODUCE SMOKE AND IT WOULD NOT POWER ON THEREAFTER. 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