BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3922443 · Received June 3, 2014

    Report

    Report Number
    9615050-2014-03787
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 6, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING A REVIEW OF THE DEVICE HISTORY INDICATED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE AND THE FAN ROTOR DOES NOT TURN AS EXPECTED. THE PROBABLE CAUSE FOR THE S233 ALARM CODE WAS DUE TO 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 DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, A REVIEW OF THE DEVICE HISTORY NOTED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323392 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA