BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    MDR report key: 6768176 · Received August 4, 2017

    Report

    Report Number
    3015876-2017-00964
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    May 5, 2017
    Report Date
    August 4, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD DEPLETED. ALTHOUGH THE HLC BATTERIES HAD DEPLETED, THE DEVICE WOULD STILL POWER ON, CHARGE AND PROVIDE DEFIBRILLATION ENERGY WHEN PROMPTED DURING TESTING. THE CAUSE OF WHAT LED TO THE HLC BATTERIES BECOMING DEPLETED, COULD NOT BE DETERMINED. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS DISPLAYING THE CHARGE-PAK INDICATOR. AFTER AN EVALUATION OF THE ELECTRONIC DEVICE LOG, IT WAS OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD BEEN DEPLETED TO "0". WITH DEPLETED HLC BATTERIES, THE DEVICE MAY NOT HAVE SUFFICIENT POWER TO PROVIDE EFFECTIVE DEFIBRILLATION ENERGY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549211 LIFEPAK EXPRESS(R) DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC EXPRESS

    Patients

    Seq Age Sex Outcome Treatment
    1