BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4113325 · Received September 15, 2014

    Report

    Report Number
    2023050-2014-00400
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE HT70 PLUS VENTILATOR WAS RECEIVED FOR EVALUATION AND REPAIRED. THE COVIDIEN FIELD SERVICE ENGINEER (FSE) PERFORMED A VISUAL INSPECTION, WHERE THEY FOUND A BROKEN L1602 COMPONENT ON THE SBC, AND IT WAS REPLACED. THE VENTILATOR WAS PLUGGED INTO AC POWER SOURCE AND POWERED ON. ONCE THE UNIT WAS POWERED ON, IT DISPLAYED THE WARNING MESSAGE ¿DATE AND TIME HAS RESET, PLEASE REPLACE COIN BATTERY¿. THE DATE AND TIME WAS CHECKED, AND IT WAS NOTICED THAT IT REVERTED THE DATE BACK TO (B)(6) 2006, AND IT REQUIRED TO BE RESET. THE VENTILATOR WAS POWERED CYCLED A FEW TIMES, AND IT RETAINED THE DATE AND TIME. THE EVENT LOGS WERE EXTRACTED AND VISUALLY CHECKED. IT EXHIBITED SEVERAL WARNINGS WERE LOGGED, SHOWING THAT THE DATE AND TIME ERROR CODE. IT WAS ALSO NOTICED THAT THERE WERE TWO SYSTEM ERROR CODES LOGGED. THE VENTILATOR WAS ALLOWED TO RUN FOR APPROXIMATELY FOUR HOURS WITHOUT ANY ERRORS. INTERNAL VISUAL INSPECTION WAS PERFORMED, AND FOUND BROKEN PIECES INSIDE THE UNIT. CHECKED THE LITHIUM COIN BATTERY VOLTAGE, THE READING OBTAIN WAS 2.8 VOLTS. THE SINGLE BOARD COMPUTER AND THE BLACK GASKET ON THE AIR INLET FILTER COVER WERE REPLACED. THE ORIGINAL 928 WORKING HOURS HAVE BEEN REVERTED BACK TO ZERO, AND EVENTS LOG HAS BEEN CLEARED, DUE TO THE REPLACEMENT OF SBC. THE CFE WAS UNABLE TO REPLICATE THE REPORTED COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE, THE HT70 PLUS VENTILATOR HAD A 'SYSTEM ERROR' ALARM, AND THERE WAS NO VENTILATION WHEN THE CIRCUIT WAS PULLED TO CHECK. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THE VENTILATOR COULD NOT BE TURNED OFF AS IT CONTINUED ALARM WITH THE ERROR MESSAGE AND THE ALARM COULD NOT BE SILENCED. THE BATTERY WAS REMOVED TO TURN OFF THE UNIT. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569471 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention