BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 4092326 · Received August 19, 2014

    Report

    Report Number
    2023050-2014-00357
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 7, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE BUT COULD NOT DUPLICATE THE REPORTED EVENT. THE CSE REPLACED THE DEVICE'S FLAT CABLE AS A PRECAUTION. THE CABLE WAS FURTHER INVESTIGATED, HOWEVER, THERE WERE NO FAULTS FOUND. THE REPORTED EVENT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING, DURING PATIENT USE, AN HT50 VENTILATOR'S INSPIRATORY TO EXPIRATORY RATIO (I:E) DISPLAY RESET TO 1:62 WITHOUT AN AUDIBLE ALARM OR OTHER NOTIFICATION. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500209 HT50 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention