BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3821123 · Received April 16, 2014

    Report

    Report Number
    9615050-2014-02731
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INITIALLY PASSED TESTING. A WHITESCREEN ERROR WAS NOT DISPLAYED DURING THE TESTING PROCEDURES. DURING IN A REVIEW OF THE DEVICE HISTORY A WHITESCREEN TIGHTLOOP MALFUNCTION ERROR WAS NOTED. DURING FURTHER TESTING, IT WAS 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. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR 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 INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, 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 ALARMED WITH A WHITESCREEN ERROR. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232686 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK