BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3802080 · Received February 4, 2014

    Report

    Report Number
    9615050-2014-00853
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 5, 2014
    Report Date
    January 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION THE DEVICE DID NOT ALARM WITH A S233 (OVERTEMPERATURE) MALFUNCTION ALARM CODE; HOWEVER, IT WAS NOTED IN THE DEVICE HISTORY. FURTHER TESTING FOUND THAT THE DEVICE FAM WAS ROTATING TO SLOWLY TO COOL THE DEVICE. THE PROBABLE CAUSE OF THE CUSTOMER REPORTED 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 DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE-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. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71593 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA