BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2941222 · Received January 17, 2013

    Report

    Report Number
    2023050-2013-00042
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    October 16, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED VENTILATOR WAS VISUALLY INSPECTED AND NO ANOMALIES WERE NOTED. UPON INTERNAL VISUAL EXAMINATION, THE INTRODUCER WAS OBSERVED TO BE OVERHEATED. THE REPORTED FAILURE WAS CONFIRMED TO BE DUE TO AN OVERHEATED AND SHORTED INDUCTOR CAUSING THE BOARD TO MALFUNCTION. REPLACING THE CONTROL BOARD RESOLVED THE ISSUE. THE VENTILATOR WILL BE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR HAD DEVICE ALERT. EVENT HISTORY SHOWS PINT FAILURE AND MOTOR SLOW. ALTHOUGH REQUESTED, NO INFO WAS RECEIVED WHETHER THE PT WAS ATTACHED TO THE VENTILATOR OR NOT IN THIS CASE. NO PT INJURY WAS REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26993 HT70 VENTILATOR CBK, HOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1