BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500

    MDR report key: 1013289 · Received March 14, 2008

    Report

    Report Number
    2023050-2008-00017
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    May 31, 2007
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    YM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER? DEVICE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. PER HOSPITAL, WHEN DEVICE STOPPED, THE VENT WAS TURNED OFF AND ON AGAIN AND THEN IT WORKED NORMALLY. DEVICE WAS REPAIRED IN THE FIELD. NO FURTHER PROBLEMS HAVE BEEN REPORTED; UNIT IS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    REPORTEDLY, DURING USE, THIS UNIT SUDDENLY STOPPED INSPIRATION TO THE PT WITHOUT ANY ALARMS. WHEN IT STOPPED, THE UNIT WAS TURNED OFF AND ON AND AGAIN WORKED NORMALLY. NO PT DEATH OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK