BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3880388 · Received April 8, 2014

    Report

    Report Number
    9615050-2014-02549
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 10, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN DOES NOT RESPOND WHEN PRESSED. THE DEVICE WAS RETURNED TO THE BIOMED DEPT WITH A REPORT OF THE TOUCHSCREEN NOT WORKING. IT WAS REPORTED THIS OCCURRED PRIOR TO PT USE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, WHEN POWERED ON THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED AND NO FURTHER TESTING COULD BE COMPLETED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210897 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA