BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 3822712 · Received May 21, 2014

    Report

    Report Number
    3015876-2014-00575
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4): DESPITE SEVERAL ATTEMPTS FROM PHYSIO-CONTROL TO GET THE DEVICE RETURNED, THE CUSTOMER DID NOT RETURN THE DEVICE FOR FURTHER EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, A CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. PHYSIO-CONTROL DISCONTINUED SERVICE AND SUPPORT OF THIS DEVICE AS OF 05/01/2010. THE CUSTOMER WAS THEREFORE ADVISED TO REPLACE THEIR DEVICE DUE TO ITS AGE AND THE LACK OF SERVICE AND SUPPORT FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT THEIR DEVICE WAS OVERHEATING, AND CAUGHT FIRE. THE DEVICE WAS CONNECTED TO AC POWER. WHEN THE DEVICE WAS UNPLUGGED FROM AC POWER, IT COOLED DOWN BUT IT WOULD HEAT UP AGAIN, AS SOON AS IT WAS CONNECTED BACK TO AC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303653 LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 10

    Patients

    Seq Age Sex Outcome Treatment
    1