BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3822892 · Received February 5, 2014

    Report

    Report Number
    9615050-2014-00923
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT PASS THE TEMPERATURE TEST WITH A PSC (POWER SUPPLY CONTROLLER) AMBIENT TEMPERATURE OF 71C (EXPECTED TEMPERATURE LESS THAN 70 DEGREES C). THIS WAS FOUND TO BE DUE TO THE FAN NOT ROTATING FAST ENOUGH TO KEEP THE PSC AMBIENT TEMPERATURE FROM EXCEEDING 70 DEGREES C. THE PROBABLE CAUSE FOR THE OVERHEATING 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 DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S233 (OVERTEMPERATURE-PSC) SERVICE ALARM CODE AND WAS REPORTED TO BE HOT TO TOUCH. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND 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
    76347 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA