BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3041957 · Received April 9, 2013

    Report

    Report Number
    3015876-2013-00281
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FAILURE ANALYSIS CENTER EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE'S READINESS DISPLAY SHOWED OK AND THAT NO OTHER ICONS WERE ILLUMINATED; HOWEVER, DUE TO A RECENT SOFTWARE UPGRADE, THERE WAS NO SELF TEST DATA AVAILABLE PRIOR TO (B)(6) 2013. THE DOWNLOADED EVENT CODES SHOWED THAT THE CHARGE-PAK ICON WAS ILLUMINATED IN THE DEVICE'S READINESS DISPLAY ON (B)(6) 2013 BECAUSE THE CHARGE-PAK WAS MISSING. IT WAS ALSO OBSERVED THAT THE DEVICE WAS ABLE TO PROVIDE DEFIBRILLATION THERAPY DURING TESTING. A CURRENT LEAK WAS IDENTIFIED ON THE DEVICE'S DIGITAL PCB ASSEMBLY DURING TESTING. THE CAUSE OF THE CURRENT LEAK WAS DUE TO A HIGH RESISTIVE PATH BETWEEN LEGS 1-2 AND LEGS 7-8 OF A RESISTOR, DESIGNATOR R35 FROM THE DIGITAL PCB ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED ALL THREE INDICATORS (SERVICE WRENCH, ATTENTION AND CHARGE PAK) AND LOGGED SEVERAL EVENT CODES. THEREFORE THE DEVICE WAS NOT OPERABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146252 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1