BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1013266 · Received March 14, 2008

    Report

    Report Number
    3015876-2008-00181
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT AN AFTERMARKET BATTERY INSTALLED IN THE DEVICE HAD A LOW CHARGE CAPACITY AND UNINSULATED BATTERY TERMINAL CONNECTORS THAT SHOWED EVIDENCE OF INTERMITTENTLY ARCING. PHYSIO REPLACED THE BATTERY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED FOR A PT IN CARDIAC ARREST, THE DEVICE POWERED DOWN BY ITSELF TWICE WHILE ATTEMPTING TO CHARGE TO 360 JOULES. THE REPORT STATES THAT THE DEVICE WAS PLUGGED INTO AC POWER AT THE TIME. THE DEVICE SUCCESSFULLY CHARGED TO 200 JOULES AND THEN A BACKUP DEVICE WAS USED TO CONTINUE THE CODE. THE PT WAS RESUSCITATED.

    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 UNK