BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3902005 · Received May 7, 2014

    Report

    Report Number
    9615050-2014-03278
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, IT WAS NOTED IN THE DEVICE HISTORY. FURTHER TESTING FOUND THAT THE DEVICE FAN WAS ROTATING TOO SLOWLY TO COOL THE DEVICE. THE PROBABLE CAUSE OF THE CUSTOMER COMPLAINT 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 THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. 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
    276796 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA