BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4251362 · Received November 5, 2014

    Report

    Report Number
    9615050-2014-05934
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 31, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE TOUCHSCREEN DID NOT PASS THE TOUCHSCREEN TEST AND THE MODE BUTTON DID NOT RESPOND WHEN PRESSED. THIS WAS DUE TO A BROKEN TOUCHSCREEN. AS INDICATED, 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 THE MODE BUTTON ON THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, NO SPECIFIC PATIENT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710028 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK