BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3850873 · Received February 12, 2014

    Report

    Report Number
    9615050-2014-01156
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION THE DEVICE DID NOT ALARM WITH A S233 (OVER-TEMPERATURE) MALFUNCTION ALARM CODE; HOWEVER, IT WAS NOTED IN THE DEVICE HISTORY. FURTHER TESTING FOUND THAT THE DEVICE FAN WAS NOT ROTATING FAST ENOUGH. THE PROBABLE CAUSE TO THE CUSTOMER REPORTED 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

    HOLD FOR LJFTHE CUSTOMER CONTACT REPORTED THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE WAS FOUND TO BE OVERHEATING. THE CUSTOMER CONTACT INDICATED THAT IT WAS UNK IF THE DEVICE WAS HOT TO TOUCH OR IF AN ERROR CODE WAS DISPLAYED. 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
    93113 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA