BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3801691 · Received April 25, 2014

    Report

    Report Number
    2023050-2014-00165
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 28, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT FROM (B)(6) STATING THAT A HT70 VENTILATOR EXPERIENCED A MALFUNCTION DURING PT USE. WHEN THE VENTILATOR WAS CONNECTED TO AN ALTERNATING CURRENT POWER SOURCE A BACKUP BATTERY FAILURE ALARM OCCURRED. THE UNIT WAS THEN RE-BOOTED AND ALL THE PARAMETER SETTINGS SHOWED ZERO. THE BACKUP BATTERY FAILURE RESOLVED WITH A REBOOT OF THE DEVICE. DURING THIS EVENT THE PT WAS MANUALLY VENTILATED AND THEN PLACED ON ANOTHER VENTILATOR. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250317 HT70 VENTILATOR CBK NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention