BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1883386 · Received October 21, 2010

    Report

    Report Number
    3015876-2010-01160
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO A FAILURE OF THE SINGLE BOARD COMPUTER (SBC) ON THE SYSTEM PCB ASSEMBLY. IT WAS OBSERVED THAT A CAPACITOR WAS NOT SOLDERED ON ONE SIDE. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    A PHYSIO-CONTROL SALES REPRESENTATIVE WAS HELPING THE CUSTOMER WITH THE CONFIGURATION OF THE DEVICE. IT WAS REPORTED THAT AFTER APPROXIMATELY 20-30 MINUTES, THE DISPLAY WENT BLANK AND THE GREEN POWER LIGHT WAS STILL ON. THEY MOVED THE DEVICE AND THE DISPLAY THEN FLICKERED ON AND OFF, AND THEN BACK ON; HOWEVER, THE DISPLAY SHOWED VERTICAL COLORED LINES AND THE SERVICE INDICATOR WAS ILLUMINATED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA