BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3023954 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00245
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES WERE DEAD, WHICH CONTRIBUTED TO THE DEVICE FAILING TO POWER ON; HOWEVER, THE CAUSE OF THE DEPLETED HLC BATTERIES WAS NOT CONCLUSIVELY DETERMINED. THE DEVICE MEASURED 8.42 MA OF OFF-CURRENT AS WELL. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES WERE DEAD, WHICH CONTRIBUTED TO THE DEVICE FAILING TO POWER ON; HOWEVER, THE CAUSE OF THE DEPLETED HLC BATTERIES WAS NOT CONCLUSIVELY DETERMINED. THE DEVICE MEASURED 8.42 MICRO AMPS OF OFF-CURRENT AS WELL. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES WERE DEAD, WHICH CONTRIBUTED TO THE DEVICE FAILING TO POWER ON; HOWEVER, THE CAUSE OF THE DEPLETED HLC BATTERIES WAS NOT CONCLUSIVELY DETERMINED. THE DEVICE MEASURED 8.42 MA OF OFF-CURRENT AS WELL. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS DISPLAYING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK). THIS IS INDICATIVE OF A DEVICE THAT WOULD NOT HAVE SUFFICIENT POWER TO PROVIDE DEFIBRILLATION SHOCKS, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126677 LIFEPAK CR(R) PLUS DEFIBRILLATOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1