BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4110399 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05246
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    FA211-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT DISPLAY A WHITESCREEN ERROR WHEN THE DEVICE WAS POWERED ON. FURTHER TESTING 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. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 A WHITESCREEN ERROR. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. 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
    573796 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK