BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR TUBING LONG LENGTH

    MDR report key: 2062517 · Received March 21, 2011

    Report

    Report Number
    3004365956-2011-00119
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 25, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS BEEN RETURNED TO MFR. INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT DID NOT PASS THE LEAK TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR TUBING LONG LENGTH VENTILATOR TUBING BZO TELEFLEX MEDICAL NA 02K1001920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK