BEUDAMED
    FDA Adverse Event Other Summary report: N

    HFJV PATIENT CIRCUIT

    MDR report key: 405976 · Received July 19, 2002

    Report

    Report Number
    1719232-2002-00001
    Event Type
    Other
    Date Received
    July 19, 2002
    Date of Event
    July 8, 2002
    Report Date
    July 18, 2002
    Manufacturer
    BUNNELL, INC.
    Product Code
    CAI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PLACED ON HIGH FREQUENCY VENTILATOR. PATIENT BREATHING CIRCUIT USED WITH VENTILATOR HAD THE PINCH TUBING CUT THROUGH IN THE PATIENT BOX. PATIENT DEVELOPED BRADYCARDIA AND DESATURATED TO 50. PATIENT BAGGED FOR 3 TO 4 MINS., AND STATS INCREASED TO 55. REPLACED CIRCUIT AND STATS RETURNED TO 85. CIRCUIT HAD BEEN CHANGED TWO DAYS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFJV PATIENT CIRCUIT PATIENT BREATHING CIRCUIT CAI BUNNELL, INC. * 2D0105

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO BUNNELL PATIENT BOX.| BUNNELL HIGH FREQUENCY JET VENTILATOR,