BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBQ 2 CHANNEL V2.01

    MDR report key: 3883112 · Received May 23, 2014

    Report

    Report Number
    9615050-2014-03617
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 23, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE ALARMED FOR S233 (OVER TEMPERATURE ERROR) MALFUNCTION ALARM CODE. DURING A REVIEW OF THE DEVICE HISTORY A S233 ALARM CODE WAS NOTED. THE PROBABLE CAUSE 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 THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE ERROR) MALFUNCTION ALARM CODE. THERE WERE NO REPORTED ADVERSE EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY THE DEVICE ALARMED WITH A S233 MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307795 SYBQ 2 CHANNEL V2.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA