BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3791428 · Received May 5, 2014

    Report

    Report Number
    3015876-2014-00505
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND OBSERVED AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL11, ON THE ANALOG PCB ASSEMBLY. THE AMOUNT OF LEAKAGE (0 UA AT AMBIENT TEMPERATURES AND 2 UA AT 30 DEGREES CELSIUS AND 90% HUMIDITY) WAS INSIGNIFICANT AND WOULD NOT HAVE CAUSED THE OBSERVED DEPLETION OF THE DEVICE'S HYBRID LAYER CAPACITOR (HLC) BATTERIES. LONG TERM TESTING OF THE DEVICE DID NOT REVEAL ANY ANOMALIES. THE DEVICE WAS ABLE TO POWER ON AND DEFIBRILLATE DURING TESTING. THE CAUSE OF THE DEPLETED HLC BATTERIES COULD NOT BE DETERMINED.

    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 INTERNAL ELECTRICAL LEAKAGE THAT HAS THE POTENTIAL TO DEPLETE THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES, WHICH COULD INHIBIT THE DEVICE'S ABILITY TO PROVIDE DEFIBRILLATION THERAPY, IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267273 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1