BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3843468 · Received March 14, 2014

    Report

    Report Number
    9615050-2014-01952
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 12, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE RIGHT SIDE OF THE DEVICE TOUCHSCREEN DID NOT RESPOND. THE DEVICE PASSED THE TOUCHSCREEN TEST AND TOUCHSCREEN CALIBRATION TEST WITHOUT ERROR. VISUAL INSPECTION REVEALED CONTAMINATION DUE TO FLUID INGRESS FOUND ON THE LEFT LOWER, LOWER RIGHT, AND UPPER RIGHT CORNERS OF THE TOUCHSCREEN. THE PROBABLE CAUSE OF THE CUSTOMER'S REPORTED EVENT WAS FLUID INGRESS. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO 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 WOULD NOT CALIBRATE ON SERVICE MODE. THERE WERE NO REPORTS OF ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153736 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA