BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3905810 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03734
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DID NOT ALARM WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE; HOWEVER, MULTIPLE S233 MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY. FURTHER TESTING FOUND THAT THE DEVICE WAS WARM TO TOUCH. THE DEVICE FAN WAS FOUND TO BE NOT ROTATING FAST ENOUGH DURING THE BATTERY CHARGING TO COOL THE DEVICE. THE PROBABLE CAUSE OF THE S233 MALFUNCTION ALARM WAS A BROKEN DEVICE COOLING 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 THAT THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNKNOWN FLOOR WITH AN UNSIGNED NOTE STATING "BROKEN". NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, A S233 MALFUNCTION ALARM CODE WAS NOTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317397 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK