BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3823007 · Received February 19, 2014

    Report

    Report Number
    9615050-2014-01275
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 7, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CTR WHEN POWERED ON THE DEVICE DISPLAYED A WHITESCREEN ERROR, "DEVICE MALFUNCTION: HW WATCHDOG ERROR AND UNEXPECTED WATCHDOG RESET." THIS WAS DUE TO A DEPLETED BACK UP BATTERY ON THE USER INTERFACE CONTROLLER (UIC). THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CTR, AFTER THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104265 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA