BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4173301 · Received October 10, 2014

    Report

    Report Number
    9615050-2014-05595
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 24, 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 RESPONDED, BUT THE KEY ALIGNMENT WAS OFF. DURING A REVIEW OF THE DEVICE HISTORY BUTTON ID: INVALID ERROR CODES WERE NOTED. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION FROM FLUID INGRESS WHICH ALTERED THE CHARACTERISTICS OF THE 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 THE DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN COULD NOT CALIBRATE AND WOULD NOT RESPOND WHEN PRESSED. 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
    642932 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA