BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3850887 · Received February 12, 2014

    Report

    Report Number
    9615050-2014-01153
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED WITH A S233 (OVERTEMPERATURE) MALFUNCTION CODE. THIS WAS FOUND TO BE DUE TO THE FAN NOT ROTATING FAST ENOUGH TO KEEP THE PSC (POWER SUPPLY CONTROLLER) TEMPERATURE FROM EXCEEDING 70 DEGREES C. THE CAUSE OF THE OVERHEATING WAS A BROKEN FAN. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DURING PREVENTATIVE MAINTENANCE AT THE USER FACILITY, THE DEVICE ALARMED WITH A "HIGH TEMP ALARM, MALFUNCTION TEMP TOO HIGH." THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93841 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA