BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2063331 · Received April 11, 2011

    Report

    Report Number
    3015876-2011-00316
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 14, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND THE POWER CORD FROM THE EVENT AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE A PARTIALLY SHORTED AC POWER CABLE. THERE WAS NO FAILURE OF THE DEVICE AS PROPER OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTINGS. FOLLOWING OTHER UNRELATED REPAIRS AND REPLACEMENT OF THE AC POWER CABLE, THE DEVICE WILL BE RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERHEATED AND CAUGHT FIRE WHILE IT WAS POWERED OFF AND PLUGGED INTO AC POWER. THE DEVICE WAS NOT IN USE AND PLACED ON THE CRASH CART WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR BYSTANDER INJURIES THAT OCCURRED DUE TO THE REPORTED EVENT. THERE WAS NO OTHER EQUIPMENT THAT WAS CONNECTED TO THE AC OUTLET AND THE FLAME DAMAGE OCCURRED AROUND THE DEVICE AC POWER INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA