BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4222849 · Received November 4, 2014

    Report

    Report Number
    2023050-2014-00459
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THE DEVICE BE RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER EVALUATED THE PRINTED CIRCUIT BOARDS AND COULD NOT VERIFY THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING USE ON A HOMECARE PATIENT, A CONTINUOUS ALARM WAS GENERATED AND AN "APPLICATION ERROR" WAS DISPLAYED. A CARE GIVER (FAMILY MEMBER) FOUND THAT VENTILATION HAD STOPPED. THE PATIENT WAS MANUALLY VENTILATED. THE CONTINUOUS ALARM COULDN'T BE STOPPED BY PRESSING THE SILENCE BUTTON. THE DEVICE WAS FORCIBLY SHUT DOWN AND REBOOTED. AT THE TIME, THE SETTING REVERTED TO THE DEFAULT SETTING. THE CARE GIVER MODIFIED THE SETTING AND CHECKED THE CIRCUIT AND CONFIRMED THAT VENTILATION RE-STARTED. AFTER THAT, THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE. THE DEVICE WAS REPLACED ON THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707573 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention