BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3823375 · Received March 20, 2014

    Report

    Report Number
    9615050-2014-02198
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 15, 2014
    Report Date
    February 20, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE WAS WARM TO TOUCH DURING TESTING. DURING A REVIEW OF THE DEVICE HISTORY S233 (OVERTEMPERATURE) MALFUNCTION ALARM CODES WERE NOTED. FURTHER TESTING FOUND THE DEVICE FAN WAS RUNNING SLOWER THAN EXPECTED. THE PROBABLE CAUSE OF THE CUSTOMER REPORTED OVERHEATING WAS DUE TO A BROKEN COOLING 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 WAS "OVERHEATING." THERE WERE NO REPORTED DELAYS OF 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
    167763 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA