BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2904268 · Received January 9, 2013

    Report

    Report Number
    3015876-2013-00028
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S DEVICE WAS EXAMINED BY A 3RD PARTY SERVICE AGENT WHO VERIFIED THE REPORTED FAILURE. THE SERVICE AGENT PERFORMED AN INTERNAL AND VISUAL EXAMINATION OF THE DEVICE WHERE HE OBSERVED THE PRESENCE OF SAND AND CORROSION. THE CUSTOMER REQUESTED THAT THE DEVICE BE RETURNED TO THEM FOR DISPOSAL. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED A 3RD PARTY PHYSIO-CONTROL SERVICE AGENT TO REPORT THAT DEVICE NO LONGER POWERED ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11703 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1