BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 5950873 · Received September 14, 2016

    Report

    Report Number
    3015876-2016-01089
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 14, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. IT WAS ALSO OBSERVED THAT THE DEVICE COULD NOT CHARGE AND SHOCK FOR DEFIBRILLATION THERAPY DUE TO THE DEPLETION OF THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICALLY SHORTED CAPACITOR, DESIGNATOR C76 ON THE ANALOG PCB ASSEMBLY. THE SHORTED CAPACITOR DEPLETED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. IT WAS ALSO OBSERVED THAT THE DEVICE COULD NOT CHARGE AND SHOCK FOR DEFIBRILLATION THERAPY DUE TO THE DEPLETION OF THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICALLY SHORTED CAPACITOR, DESIGNATOR C76 ON THE ANALOG PCB ASSEMBLY. THE SHORTED CAPACITOR DEPLETED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. IT WAS ALSO OBSERVED THAT THE DEVICE COULD NOT CHARGE AND SHOCK FOR DEFIBRILLATION THERAPY DUE TO THE DEPLETION OF THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICALLY SHORTED CAPACITOR, DESIGNATOR C76 ON THE DIGITAL PCB ASSEMBLY. THE SHORTED CAPACITOR DEPLETED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED THE CHARGE-PAK AND ATTENTION ICONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DOWNLOADED DEVICE DATA LOGS INDICATED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD BECOME DEPLETED AND THAT THE DEVICE WOULD NOT HAVE BEEN ABLE TO DELIVER DEFIBRILLATION ENERGY IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602508 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1