BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6186285 · Received December 19, 2016

    Report

    Report Number
    2023050-2016-00754
    Event Type
    Injury
    Date Received
    December 19, 2016
    Report Date
    October 4, 2018
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). A COVIDIEN FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED CONDITION. THEY REPLACED THE PUMP AND THE MIXER GASKET. THE FSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) NUMBER ADDED. CORRECTION TO CONTACT INFORMATION. CORRECTION TO EVALUATION CODES RESULT AND CONCLUSION. DEVICE EVALUATION SUMMARY: THE PUMP/MANIFOLD ASSEMBLY WAS RETURNED TO MEDTRONIC FOR FAILURE INVESTIGATION. THE PUMP WAS OBSERVED TO MAKE A CHATTERING SOUND DURING OPERATION. UPON FURTHER INSPECTION OF THE PUMP, ONE PISTON BUSHING WAS FOUND TO BE DISLODGED FROM THE SMALL CAP END OF THE PUMP HOUSING. DEBRIS WAS OBSERVED NEAR THE LINEAR PISTON BEARINGS, INDICATING WEAR IN THE BEARINGS. NO SIGNS OF WEAR WAS OBSERVED IN THE DOGBONE BEARINGS. NO CORRECTIVE ACTION IS REQUIRED, BECAUSE NO TREND HAS BEEN IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE HT70 PLUS VENTILATOR GENERATED AN ABNORMAL NOISE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837303 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention