BEUDAMED
    FDA Adverse Event Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3970690 · Received June 30, 2014

    Report

    Report Number
    9615050-2014-04240
    Date Received
    June 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED; HOWEVER, TONES WERE HEARD WHEN THE KEYS WERE PRESSED. THE PROBABLE CAUSE WAS DUE TO A BROKEN TOUCHSCREEN. THIS 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 WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE FRONT BEZEL NEEDS REPLACED. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING, THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378683 SYMBIQ DUAL CHANNEL 80 FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1