BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3982712 · Received July 24, 2014

    Report

    Report Number
    9615050-2014-04578
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 9, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, INACCURATE DELIVERY OCCURRED ON CHANNEL B OF THE DEVICE. PRIOR TO TESTING, THE CUSTOMER CONTACT REPORTED DURING PREVENTIVE MAINTENANCE TESTING IN THE BIOMEDICAL DEPARTMENT THE DEVICE DID NOT PASS THE LED TEST. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN 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
    434867 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA