BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 7123255 · Received December 15, 2017

    Report

    Report Number
    3015876-2017-01601
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    September 28, 2017
    Report Date
    December 15, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CONTACTED PHYSIO-CONTROL TO REPORT THAT THE ATTENTION AND SERVICE WRENCH ICONS WERE PRESENT ON THEIR DEVICE. THEY REPLACED THE CHARGE-PAK AND THE DEVICE STILL DISPLAYED THE SERVICE WRENCH ICON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899641 LIFEPAK CR(R) PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1