BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9617604-2008-00068

    MDR report key: 1113823 · Received May 29, 2008

    Report

    Report Number
    9617604-2008-00068
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Product Code
    FPA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL'S INVESTIGATION INTO THIS EVENT IS STILL IN PROCESS. A SMITHS MEDICAL REP WAS SENT TO THE HOSP, AS THEY WOULD NOT RELEASE THE SAMPLE, AND HIS PRELIMINARY FINDING WAS THAT (ON A RETAIN LOT SAMPLE) LEAKAGE OUT OF THE TOP OF THE DRIP CHAMBER WAS OBSERVED. THIS FAILURE MODE APPEARS TO BE RELATED TO A BOND ISSUE. THE RETAIN SAMPLES HAVE BEEN FORWARDED TO OUR MFG SITE FOR FULL INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FPA

    Patients

    Seq Age Sex Outcome Treatment
    1