BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4173262 · Received October 10, 2014

    Report

    Report Number
    9615050-2014-05586
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE SERVICE CTR FOUND THE DEVICE TOUCHSCREEN RESPONDED; HOWEVER, THE KEYS WERE OUT OF ALIGNMENT. A REVIEW OF THE DEVICE HISTORY INDICATED BUTTON ID: INVALID AND A TOUCHSCREEN: FAIL ERROR CODES. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION FOUND ON THE BOTTOM OF THE TOUCHSCREEN CAUSED BY FLUID INGRESS. THIS 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 THAT, DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE EXPERIENCED A "TOUCHSCREEN FAILURE" AND THE TOUCHSCREEN WOULD NOT CALIBRATE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643048 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA