BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3902068 · Received May 2, 2014

    Report

    Report Number
    9615050-2014-03197
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE TOUCHSCREEN DOES NOT RESPOND WHEN PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING, THE DEVICE DID NOT PASS THE TOUCHSCREEN TEST DUE TO NO RESPONDING AS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266080 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA