BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 2925378 · Received January 17, 2013

    Report

    Report Number
    9615050-2013-00096
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION THE DEVICE WOULD NOT POWER ON USING AC POWER. THE DISPLAY REMAINED BLACK AND THE DEVICE SOUNDED AN AUDIBLE ALARM FROM THE SECONDARY BEEPER. THIS WAS DUE TO SPILLAGE ON THE POWER MANAGEMENT PRINTED CIRCUIT BOARD. THE CAUSE OF THE SPILLAGE WAS USE IN THE CUSTOMER ENVIRONMENT. DURING TESTING, NO WHITESCREEN ERRORS WERE DISPLAYED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A WHITESCREEN ERROR. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FROM THE CENTRAL SUPPLY DEPT WITH A REPORT OF "NO DISPLAY ON POWER UP, GIVES A TONE ALSO LIKE IT DOES WITH A SOFTWARE ERROR." DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THE "PUMP HAD NO DISPLAY UPON POWER ON. AFTER A FEW SECONDS IT GAVE A CONSTANT ALARM AND THERE WAS A WHITE SCREEN, WITH RED WRITINGS." THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26749 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA