BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP NEW

    MDR report key: 1931166 · Received November 11, 2010

    Report

    Report Number
    2921482-2010-00878
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 12, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTING MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN AIR WAS IN THE TUBING DISTAL TO THE DEVICE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 SP NEW 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA