BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3955379 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03973
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY, DURING TESTING, THE DEVICE DID NOT ALARM WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE; HOWEVER, IT WAS NOTED IN THE DEVICE HISTORY. THE PROBABLE CAUSE OF THE S233 MALFUNCTION ALARM CODE WAS A BROKEN FAN. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE-PSC) MALFUNCTION ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, A S233 MALFUNCTION ALARM CODE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347672 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1