BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3894604 · Received May 21, 2014

    Report

    Report Number
    9615050-2014-03531
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE TOUCHSCREEN DID NOT RESPOND. THE PROBABLY CAUSE WAS DUE TO THE DEVICE TOUCHSCREEN BEING OUT OF CALIBRATION AND NEEDED TO BE CLEANED. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 WAS NOT RESPONDING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED, "TOUCHSCREEN NO RESPONDING." 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 INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304092 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA