BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6

    MDR report key: 50609 · Received November 15, 1996

    Report

    Report Number
    2112667-1996-00030
    Event Type
    Malfunction
    Date Received
    November 15, 1996
    Date of Event
    July 29, 1996
    Report Date
    November 14, 1996
    Manufacturer
    OHMED
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PLANNED MAINTENANCE VISIT, CO SERVICE REP NOTED OUTPUT WAS NOT WITHIN SPECIFICATION. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 CALIBRATED VAPORIZER CAD OHMED TEC 6 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other