BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3832717 · Received March 26, 2014

    Report

    Report Number
    9615050-2014-02297
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED INITIAL TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE ALARMED WITH AN S136 MALFUNCTION ALARM CODE. DURING FURTHER TESTING AT THE SERVICE CTR THE DEVICE DID NOT PASS THE SDRAM TEST WHICH MAY HAVE CAUSED THE CUSTOMER'S REPORTED S136 AND THE WHITESCREEN ERROR DURING SERVICE CTR TESTING. THIS WAS DUE TO THE SOM2 HARDWARE MODULE.THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CTR WITH A REPORT FROM THE CUSTOMER CONTACT THE DEVICE ALARMED WITH AN S136 (WATCHDOG ERROR-UIC) MALFUNCTION ALARM CODE. NO ADDITIONAL INFO WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER DURING VERIFICATION TESTING AT THE SERVICE CTR THE DEVICE ALARMED WITH AN S136 (WATCHDOG ERROR - UIC) MALFUNCTION ALARM CODE AND DISPLAYED A WHITESCREEN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176658 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA