BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCS OXIPORT FIBEROPTIC BLADE - MILLER

    MDR report key: 305486 · Received November 15, 2000

    Report

    Report Number
    2429473-2000-00102
    Event Type
    Malfunction
    Date Received
    November 15, 2000
    Date of Event
    November 6, 2000
    Report Date
    November 13, 2000
    Manufacturer
    RUSCH, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING INTUBATION IT WAS NOTED THAT THERE WAS A CRACK WHERE THE O2 TUBE IS SOLDERED TO THE LARYNGOSCOPE BLADE BODY. DURING EXAM OF THE BLADE AFTER USE, THE O2 TUBE FELL OFF ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCS OXIPORT FIBEROPTIC BLADE - MILLER LARYNGOSCOPE BLADE W/ OXYGEN PORT CAI RUSCH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN