BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT50 VENTILATOR

    MDR report key: 7226733 · Received January 29, 2018

    Report

    Report Number
    2023050-2018-00003
    Event Type
    Death
    Date Received
    January 29, 2018
    Date of Event
    January 6, 2018
    Report Date
    January 29, 2018
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE FROM THE CUSTOMER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING USE, THE CUSTOMER REPORTED THAT THE HT50 VENTILATOR CONTINUED VENTILATION AS THE PATIENT HYPOVENTILATED DURING A PROCEDURE. THE INTENSIVE CARE UNIT (ICU) RESPIRATORY THERAPIST (RT) ¿ADJUSTED¿ THE ENDOTRACHEAL TUBE (ETT) AND AMBU BAGGED THE PATIENT AND THE PATIENT¿S VITAL SIGNS, HEMODYNAMICS IMMEDIATELY RECOVERED. THE PATIENT WENT INTO CARDIAC ARREST SHORTLY AFTER AND EXPIRED. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68576 HT50 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Death