BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 4220900 · Received November 3, 2014

    Report

    Report Number
    2023050-2014-00452
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE SHOWED SLIGHT DARKENING OF THE GREASE ON THE LINEAR BEARINGS, AND NO OTHER ISSUES. IT WAS INSTALLED INTO A VENTILATOR TEST UNIT, AND ALLOWED TO VENTILATE FOR THREE CONSECUTIVE DAYS, WITH NO ISSUES OBSERVED. THE CUSTOMER REPORTED MALFUNCTION COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE OF THE HT50 VENTILATOR, AN ALARM WAS GENERATED. A NURSE CONFIRMED THAT THE MANOMETER DIDN'T MOVE, ALTHOUGH THE CIRCUIT WAS STILL CONNECTED. THE DEVICE HAD STOPPED CYCLING. A "MOTOR FAULT" ERROR WAS DISPLAYED. WHEN THE SILENCE/RESET BUTTON WAS PRESSED, THE DEVICE SHUT DOWN. THE PATIENT WAS TRANSFERRED TO ANOTHER UNIT. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702201 HT50 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention