BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3883233 · Received May 23, 2014

    Report

    Report Number
    9615050-2014-03593
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 SLIGHTLY OFF AND A REVIEW OF THE DEVICE HISTORY INDICATED MULTIPLE "BUTTON ID: INVALID" ERRORS. ADDITIONAL TESTING FOUND FLUID INGRESS ON THE BOTTOM OF THE TOUCHSCREEN CONNECTORS WHICH WAS THE PROBABLE CAUSE OF THE NON RESPONSIVE 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 WOULD NOT CALIBRATE. 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
    309075 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA