BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2934911 · Received January 4, 2013

    Report

    Report Number
    2023050-2013-00010
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 19, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, IT WAS FOUND THAT THE POWER CHARGERS HAD BROKEN TIPS. THE CHARGER ALSO HAD FRAYED WIRES THAT HAD SPARKED A COUPLE TIMES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5796 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1