BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4177547 · Received October 16, 2014

    Report

    Report Number
    2023050-2014-00413
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE USER FACILITY, THE DEVICE WAS REPORTED TO BE REPAIRED AND RETURNED TO THE USER FOR CLINICAL USE. THE BATTERY WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE BATTERY WAS RECEIVED BY COVIDIEN FOR AN INVESTIGATION. THE COMPLAINT'S REFERENCE TO "BACKUP BATTERY FAILURE" COULD INDICATE A FAILURE IN BACKUP BATTERY DUE TO COMMUNICATION FAILURE WITH HOST PROCESSOR OR THE CAPACITY WAS BELOW 1 AH. THE BATTERY WAS INSTALLED INTO AN HT70 TEST UNIT FOR OVER 42 HOURS, AND SUBJECTED TO NUMEROUS POWER UP, POWER DOWN CYCLES, BOTH WITH AND WITHOUT AC CONNECTED, AND WITH AND WITHOUT VENTILATION. THE INTEGRATED POWER PAC AND THIS BACKUP BATTERY WERE ALLOWED TO BE EXHAUSTED WITH AC REMOVED, FORCING AN AUTOMATIC SHUTDOWN. EXCEPT FOR THE ANTICIPATED BATTERY LOW ALARMS, NO BATTERY "FAILURE" ALARM WAS RECEIVED. THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS FOUND TO FUNCTION PER SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE AN HT70 VENTILATOR EXPERIENCED A BACKUP BATTERY FAILURE ALERT WHILE THE UNIT WAS CONNECTED TO THE ALTERNATING CURRENT (AC) POWER SOURCE. THE PATIENT'S FATHER NOTICED THE ALARM AND CALLED A SERVICE TECHNICIAN. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659169 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention