BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9617604-2008-00036

    MDR report key: 1041043 · Received March 31, 2008

    Report

    Report Number
    9617604-2008-00036
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Product Code
    JOH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS: PRELIMINARY INVESTIGATION CONFIRMED LEAKAGE. THE LEAKAGE PORTION WAS LOCATED IN THE BONDED PORTION BETWEEN THE CUFF AND THE TUBE. THE SAMPLE HAS BEEN FORWARDED TO THE MFG SITE FOR FURTHER INVESTIGATION. UPON RECEIPT OF THE COMPLETED INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1