BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 5970795 · Received September 22, 2016

    Report

    Report Number
    3015876-2016-01127
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    August 9, 2016
    Report Date
    September 22, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS VERIFIED THE HLC DEPLETION THROUGH THE ELECTRONIC DEVICE LOGS; HOWEVER DURING DEVICE TESTING, THERE WAS NO DEVICE ISSUE OBSERVED.  THE HLC BATTERIES HAD RECHARGED TO A NORMAL LEVEL FOLLOWING THE SHORT DEPLETION AND NORMAL DEVICE FUNCTIONALITY WAS OBSERVED.  THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING ITS CHARGE-PAK AND ATTENTION ICONS. AFTER AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE DOWNLOAD INDICATES THE INTERNAL HLC BATTERIES HAD PREVIOUSLY BEEN DEPLETED. DEPLETED HLC BATTERIES COULD LEAD TO A POWER ISSUE AFFECTING THE FUNCTIONALITY OF THE DEVICE. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623170 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1