BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2072589 · Received April 22, 2011

    Report

    Report Number
    3015876-2011-00345
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 24, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER INDICATED THEY WOULD WORK WITH THE THIRD-PARTY THEY PURCHASED THE DEVICE FROM. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO CONFIRM RESOLUTION OF THE REPORTED FAILURE; HOWEVER, NO ADD'L INFO APPEARS TO BE FORTHCOMING. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVAL. THE CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD LOGGED MULTIPLE FAULT CODES. THERE WAS NO PT USE INITIALLY ASSOCIATED WITH THE REPORTED FAILURE. UPON F/U BY PHYSIO-CONTROL, IT WAS REPORTED THAT THE DEVICE FAILED TO DETECT A PT CONNECTION VIA QUIK-COMBO DEFIBRILLATION ELECTRODES. THE PT WAS ONLY BEING MONITORED AND WAS NEVER IN A CARDIAC ARREST SITUATION. IT WAS REPORTED THAT THE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK