BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 2470977 · Received February 22, 2012

    Report

    Report Number
    2023050-2012-00014
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    December 28, 2011
    Report Date
    February 2, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): EVAL SUMMARY: THE HT50 VENTILATOR WAS RECEIVED AND INSPECTED FOR ANY VISUAL DISCREPANCIES, NONE WERE FOUND. UPON CONNECTING THE UNIT TO AN AC POWER SUPPLY, THERE WAS A 'SYSTEM ERROR' MESSAGE WITH A CONSTANT ALARM. THE REPORTED FAILURE WAS CONFIRMED. THE CAUSE FOR THIS EVENT IS DUE TO AN ABRUPT SHUT DOWN OF THE VENTILATOR. BASED ON THE MONTHLY TREND TARGET COMPLAINT CHART, HT50 COMPLAINTS WHERE THE VENTILATOR STOPPED VENTILATING ARE OF LOW OCCURRENCE AND THE TREND IS UNDER THE ESTABLISHED TARGET LIMIT. WE WILL CONTINUE TO MONITOR NEW COMPLAINTS AND TRENDS OF THIS TYPE.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, THE HT50 VENTILATOR SHUT DOWN. THE CAUSE FOR THE POWER INTERRUPTION WAS DUE TO A POWER SURGE ISSUE. UPON THE RETURN OF POWER, IT WAS REPORTED THAT DURING THE 'LOADING' PHASE, THE VENTILATOR FROZE AND DID NOT VENTILATE. THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED BEFORE TRANSFERRING TO ANOTHER VENTILATOR. THERE WERE NO REPORTED ADVERSE PT EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention