BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4194050 · Received October 22, 2014

    Report

    Report Number
    3015876-2014-01256
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 29, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 VERY SUDDENLY. ALTHOUGH THE HLC BATTERIES HAD DEPLETED THE DEVICE WOULD STILL POWER ON, CHARGE AND PROVIDE DEFIBRILLATION ENERGY WHEN PROMPTED DURING TESTING. PHYSIO OBSERVED ELECTRICALLY LEAKY FILTERS, DESIGNATORS FL9 AND FL10, FROM THE ANALOG PCB ASSEMBLY; HOWEVER, THE AMOUNT OF LEAKAGE CURRENT WAS INSUFFICIENT TO CAUSE THE HLC BATTERY DEPLETION THAT WAS OBSERVED. THE CAUSE OF THE REPORTED ISSUE WAS DEPLETED HLC BATTERIES; HOWEVER, WHAT LED TO SUDDEN DEPLETION OF THE HLC BATTERIES 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 THEIR DEVICE HAD DISPLAYED A PREMATURE LOW-BATTERY INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD DEPLETED TO THE POINT WHERE THE DEVICE'S ABILITY TO POWER ON AND PROVIDED DEFIBRILLATION ENERGY, IF NECESSARY, MAY BE COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672929 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1