BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3955450 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03978
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    March 18, 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
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE SERVICE CENTER FOUND THE DEVICE TOUCHSCREEN WAS RESPONSIVE BUT THE KEYS WERE OUT OF ALIGNMENT AND THEREFORE THE DEVICE COULD NOT BE PROGRAMMED. THE PROBABLE CAUSE WAS DUE TO DRY CONTAMINATION CAUSED BY FLUID INGRESS FOUND ON THE TOUCHSCREEN CONNECTORS. 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 CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY THE DEVICE TOUCHSCREEN DID NOT PASS THE CALIBRATION TEST. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346672 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA