BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4173509 · Received October 10, 2014

    Report

    Report Number
    9615050-2014-05577
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 25, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE DID NOT PASS THE TOUCHSCREEN TEST AND WAS OUT OF CALIBRATION. 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 THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT STATED, "NO RESPONSE FROM TOUCHSCREEN." NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE TOUCHSCREEN TEST AND THE TOUCHSCREEN WAS OUT OF CALIBRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642847 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK