BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3883115 · Received May 23, 2014

    Report

    Report Number
    9615050-2014-03604
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    HOSPIRACOSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    Z-0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. FURTHER TESTING FOUND THAT THE TOUCHSCREEN WAS OUT OF CALIBRATION WHICH WAS THE PROBABLE CAUSE OF THE NONRESPONSIVE 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 THE DEVICE TOUCHSCREEN INTERMITTENTLY DOES NOT RESPOND WHEN PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. 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 OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN WAS UNRESPONSIVE AT START UP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307796 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRACOSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK