BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3092476 · Received May 3, 2013

    Report

    Report Number
    3015876-2013-00357
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL MEDWATCH FORM INDICATES: THE FACILITY BIOMED EVALUATED THE DEVICE AND REPORTED THAT HE HAD TO PUSH THE CHARGE BUTTON ON THE PADDLES HARD FOR IT TO RESPOND. THE BIOMED USED ANOTHER NEWLY PURCHASED SET OF PADDLES WITH THE DEVICE AND OBSERVED PROPER OPERATION. PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN FOR EVALUATION AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. THE INITIAL MEDWATCH FORM SHOULD INDICATE: THE FACILITY BIOMED EVALUATED THE DEVICE AND REPORTED THAT HE HAD TO PUSH THE CHARGE BUTTON HARDER THAN NORMAL ON THE DEFIBRILLATION PADDLES, FOR IT TO RESPOND. THE BIOMED USED ANOTHER NEWLY PURCHASED SET OF PADDLES WITH THE DEVICE AND OBSERVED PROPER OPERATION. THE DEVICE WAS THEN RETURNED TO PHYSIO FOR ADDITIONAL EVALUATION. PHYSIO-CONTROL EVALUATED THE DEVICE AND HAS BEEN UNABLE TO VERIFY THE REPORTED FAILURE. THE HARD PADDLES ASSEMBLY WAS NOT RETURNED TO PHYSIO-CONTROL. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56 SUPPLEMENTAL INFORMATION: PHYSIO-CONTROL FURTHER EVALUATED THE RETURNED DEVICE AND HAS BEEN UNABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO DID OBSERVE THAT THE DEVICE BATTERY WAS LOW BUT IT IS UNKNOWN IF THIS WAS RELATED TO THE REPORTED FAILURE TO CHARGE DEFIBRILLATION ENERGY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE FACILITY BIOMED EVALUATED THE DEVICE AND REPORTED THAT HE HAD TO PUSH THE CHARGE BUTTON ON THE PADDLES HARD FOR IT TO RESPOND. THE BIOMED USED ANOTHER NEWLY PURCHASED SET OF PADDLES WITH THE DEVICE AND OBSERVED PROPER OPERATION. PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN FOR EVALUATION AND CONTINUES TO INVESTIGATE THE REPORTED EVENT.PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO CHARGE EITHER FROM PADDLES OR FROM THE DEVICE FRONT PANEL DURING A PATIENT EVENT. THE DEVICE WAS IN USE DURING A CATHETERIZATION PROCEDURE AND THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (V-TACH). THE NURSES THAT WERE OPERATING THE DEVICE DID NOT HAVE ELECTRODES AND WERE USING PADDLES TO PROVIDE CARE. THE OPERATORS WERE EVENTUALLY ABLE TO CHARGE AND DELIVERED A DEFIBRILLATION SHOCK TO THE PATIENT. THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193686 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR