BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3314387 · Received August 28, 2013

    Report

    Report Number
    3015876-2013-00771
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Date of Event
    July 12, 2013
    Report Date
    August 5, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U46, OF THE ANALOG PCB ASSEMBLY. LEG 7 OF IC U46 REMAINED AT ZERO (0) VOLTS INSTEAD OF 2.35 VOLTS, WHICH LED TO THE DEVICE NOT RECOGNIZING SHOCKABLE RHYTHMS.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER ON THE INITIAL MEDWATCH REPORT INDICATED: 3202359. CATALOG NUMBER ON THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: 3200731. PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U46, OF THE ANALOG PCB ASSEMBLY. LEG 7 OF IC U46 REMAINED AT ZERO (0) VOLTS INSTEAD OF 2.35 VOLTS, WHICH LED TO THE DEVICE NOT RECOGNIZING SHOCKABLE RHYTHMS. PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U46, OF THE ANALOG PCB ASSEMBLY. LEG 7 OF IC U46 REMAINED AT ZERO (0) VOLTS INSTEAD OF 2.35 VOLTS, WHICH LED TO THE DEVICE NOT RECOGNIZING SHOCKABLE RHYTHMS. 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 A SERVICE WRENCH PRESENT ON THE DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.UPON EXAMINATION OF THE DEVICE, PHYSIO OBSERVED THAT IT WAS UNABLE TO DETECT SHOCKABLE RHYTHMS. THE UNIT WOULD STATE "NO SHOCK ADVISED" INAPPROPRIATELY. AS A RESULT, THE DEVICE WOULD NOT ABLE TO PROVIDE DEFIBRILLATION ENERGY, IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422088 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1