BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1568485 · Received December 14, 2009

    Report

    Report Number
    3003135857-2009-00028
    Event Type
    Other
    Date Received
    December 14, 2009
    Date of Event
    April 22, 2009
    Report Date
    December 9, 2009
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS INC.
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - EVAL OF THE RETURNED VENTILATOR FOUND AN ERROR MESSAGE OF "MOTOR FAULT" INDICATED ON THE DISPLAY ALONG WITH A DEVICE ALERT ALARM. FURTHER EVAL FOUND THE MAIN BOARD TO BE THE SOURCE OF THIS FAILURE. THE MAIN BOARD IN QUESTION WAS FORWARDED TO ITS MFR FOR A ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER 20 MINUTES OF VENTILATION ON A PT, THE VENTILATOR GAVE A DEVICE ALERT WITH LIT LED AND THEN IMMEDIATELY SHUT DOWN WITH AUDIBLE ALARM. THE PT WAS IMMEDIATELY AMBU BAGGED BY THE HOSP STAFF AND SWITCHED TO ANOTHER VENTILATOR. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS INC. HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention