BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3963336 · Received June 19, 2014

    Report

    Report Number
    9615050-2014-04077
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE TOUCHSCREEN RESPONDED WHEN PRESSED EXCEPT FOR THE DAMAGED PORTION OF THE TOUCHSCREEN. DURING A REVIEW OF THE DEVICE HISTORY, TOUCHSCREEN "BUTTON ID: INVALID" AND "TOUCHSCREEN: FAIL" ERROR CODES WERE NOTED. THE PROBABLE CAUSE OF THE DAMAGED TOUCHSCREEN COULD NOT BE DETERMINED DURING TESTING; HOWEVER, THE PROBABLE CAUSE OF THE NON RESPONSIVE TOUCHSCREEN WAS DUE TO CONTAMINATION FROM FLUID INGRESS ON THE BOTTOM OF THE 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 CUSTOMER CONTACT REPORTED THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN WAS NOTED TO BE DAMAGED AND DID NOT RESPOND WHEN PRESSED AT THE DAMAGED SPOT. 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
    359397 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA