BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2941252 · Received January 17, 2013

    Report

    Report Number
    2023050-2013-00038
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 8, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, ADD'L PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT TRANSFER, A "SWITCHED TO BACKUP BATTERY" ALARM OCCURRED. THIS WAS RESOLVED UPON EXCHANGING THE POWER PAC BATTERY. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26994 HT70 VENTILATOR CBK, HOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1