BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3962897 · Received June 11, 2014

    Report

    Report Number
    9615050-2014-03953
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 21, 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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE PASSED TESTING BY RESPONDING WHEN PRESSED; HOWEVER, THE KEY ALIGNMENT WAS OFF CENTERED AND A REVIEW OF THE DEVICE HISTORY INDICATED MULTIPLE TOUCHSCREEN FAIL ERRORS. ADDITIONAL TESTING FOUND FLUID INGRESS ON THE BOTTOM OF THE TOUCHSCREEN WHICH WAS THE PROBABLE CAUSE OF THE NONRESPONSIVE TOUCHSCREEN. FURTHER TESTING FOUND THAT THE GROUND PRONG OF THE AC POWER CORD WAS BENT. THE PROBABLE CAUSE WAS REMOVING THE PLUG FROM THE OUTLET AT AN ANGLE. THE 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 TOUCHSCREEN CALIBRATION TEST. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS ANO 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
    345012 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA