BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3172389 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01528
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 10, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INITIALLY PASSED TESTING; HOWEVER, A WHITESCREEN ERROR WAS DISPLAYED DURING FURTHER TESTING. TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT PASS THE SDRAM TEST WHICH MAY HAVE CAUSED THE CUSTOMER'S REPORTED WHITESCREEN ERROR. THIS IS DUE TO THE SOM2 HARDWARE MODULE. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. CUSTOMER NOTIFICATION DATED (B)(4) 2013. 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 TO WHITESCREEN ERROR. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "WHITE SCREEN." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFICATION PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS, AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249556 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK