BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3802767 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01411
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TOUCHSCREEN DID NOT PASS THE TOUCHSCREEN TEST. FURTHER TESTING FOUND CORROSION ON THE TOUCHSCREEN DUE TO FLUID INGRESS. THIS 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 PRIOR TO PT USE, THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. THERE WAS NO REPORTS OF ANY ADVERSE PATIENT 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
    109018 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA