BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4102277 · Received August 27, 2014

    Report

    Report Number
    9615050-2014-05003
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    July 24, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    FA210-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE ALARMED WITH AN S205 (BATTERY FAILURE) ERROR CODE. THE PROBABLE CAUSE WAS DUE TO THE SECONDARY SPEAKER WAS NOT WORKING DUE TO A DISCONNECTED CABLE FROM THE COIN CELL T THE POWER SUPPLY PRINTED CIRCUIT BOARD. THE ROOT CAUSE IDENTIFIED WAS DUE TO INCORRECT INSTALLATION OF COMPONENTS DURING CONFIGURATION CHANGE UP OF THE PSC (POWER SUPPLY CONTROLLER) PRINTED CIRCUIT BOARD. IN ADDITION, THE COIN CELL BATTERY WAS FOUND DEPLETED. THIS CAN ALSO CAUSE A S205 MALFUNCTION ALARM CODE. 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 CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE FAILED THE PVT AUDIO TEST. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN S205 (BATTERY FAILURE) ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522652 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA