BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6608541 · Received June 2, 2017

    Report

    Report Number
    2023050-2017-05380
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 16, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: BRAND NAME CHANGED TO HT70 PLUS VENTILATOR; CATALOG # CHANGED TO HT70; SERIAL NUMBER CHANGED TO (B)(4); PMA/510(K) 3 WAS CORRECTED TO K111146; DEVICE MANUFACTURE DATE CHANGED TO 2013-01-01; (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN HT70 PLUS VENTILATOR MOTOR PUMP WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. A REPLACEMENT PUMP WAS TO BE PROVIDED. THE PUMP/MANIFOLD ASSEMBLY WAS RETURNED TO MEDTRONIC¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO WEAR OF THE CIRCULAR BEARINGS FOR BOTH THE LINKING ARM AND MOTOR SHAFTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HT70 VENTILATOR MOTOR PUMP BROKE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389384 HT70 PLUS VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1