BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2772087 · Received October 4, 2012

    Report

    Report Number
    3015876-2012-00733
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. PHYSIO-CONTROL WILL RETURN THE DEVICE TO THE CUSTOMER FOR USE AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. A CONCLUSIVE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CHARGED TO 200 JOULES BUT POWERED OFF WHEN THE USER PRESSED THE SHOCK BUTTON TO DELIVER THE ENERGY. THE OPERATOR DID NOT ATTEMPT TO TURN THE DEVICE BACK ON DURING THE EVENT. A SECOND DEFIBRILLATOR WAS RETRIEVED WITHIN 10 TO 20 SECONDS AND UTILIZED TO DELIVER THERAPY TO THE PATIENT. THE PATIENT ULTIMATELY PASSED AWAY BUT THE OPERATOR INDICATED THAT IT WAS NOT EQUIPMENT RELATED. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    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