BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3191523 · Received June 26, 2013

    Report

    Report Number
    3015876-2013-00553
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE THIRD PARTY BIOMED RECEIVED THE DEVICE WITHOUT A CHARGE-PAK AND IT IS UNKNOWN HOW LONG THE DEVICE WAS WITHOUT IT. PHYSIO-CONTROL PROVIDED THE BIOMED TECHNICAL ASSISTANCE AND RECOMMENDED THE CUSTOMER REPLACE THE DEFIBRILLATOR. FURTHER FOLLOW UP WITH THE REPORTER FOR ADDITIONAL INFORMATION WAS UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS. THEREFORE, A CONCLUSIVE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A THIRD PARTY BIOMED REPORTED THAT THE DEVICE HAD ALL THREE (CHARGE-PAK, ATTENTION AND WRENCH) ICONS ILLUMINATED. THE DEVICE INTERNAL HLC BATTERY IS LIKELY DEPLETED TO A CRITICAL LEVEL AND IT COULD NOT PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290310 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1