BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3941167 · Received July 17, 2014

    Report

    Report Number
    3015876-2014-00819
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    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). THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THEY HAVE EVALUATED THE DEVICE AND HAS BEEN UNABLE TO DUPLICATE OR VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY. THE CUSTOMER STATED THAT THEIR PATIENT CODED AND THIS DEVICE WAS INITIALLY ABLE TO SUCCESSFULLY DELIVER DEFIBRILLATION ENERGY TO THE PATIENT MULTIPLE TIMES. THE PATIENT WAS THEN TRANSFERRED TO THE CT LAB AND LATER, THE PATIENT CODED AGAIN. DURING THIS CODE, THE DEVICE LOST POWER DURING THE DEFIBRILLATION CHARGE CYCLE. ONCE THIS DEVICE LOST POWER, THE STAFF WAS ABLE TO DEPLOY A BACK UP DEVICE IMMEDIATELY AND PROVIDED ADDITIONAL THERAPY TO THE PATIENT. THE PATIENT SURVIVED THE EVENT AND DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418897 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1