BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 6201112 · Received December 22, 2016

    Report

    Report Number
    2023050-2016-00779
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    September 22, 2016
    Report Date
    December 13, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THE CONNECTION BETWEEN THE MIXER AND THE OXYGEN TUBING SEEMED LOOSE. ALTHOUGH REQUESTED, THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN. ALTHOUGH MEDTRONIC-COVIDIEN WAS NOT AUTHORIZED TO CONDUCT EVALUATE/REPAIR THE DEVICE, THE CUSTOMER RETURNED THE OXYGEN MIXER. THE EVALUATION AND REPAIR OF THE OXYGEN MIXER HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE OXYGEN MIXER WAS RECEIVED AND ALTHOUGH THE CUSTOMER REPORTED ISSUE OF A LEAK BETWEEN THE PRESSURE RESISTANCE TUBE AND THE MIXER CONNECTION WAS VERIFIED; THE ROOT CAUSE OF THE VOLUME MEASUREMENT COULD NOT BE DETERMINED AND THERE WERE NO OTHER ANOMALIES OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE THE HT70 VENTILATOR HAD AN OXYGEN LEAK. PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848044 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention