BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4109756 · Received September 15, 2014

    Report

    Report Number
    2023050-2014-00398
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 19, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT'S REFERENCE TO "BACKUP BATTERY FAILURE" COULD INDICATE A FAILURE IN THE BACKUP BATTERY DUE TO A COMMUNICATION FAILURE WITH THE HOST PROCESSOR OR ITS CAPACITY IS BELOW 1 AH. THE RETURNED BATTERY WAS INSTALLED INTO AN HT70 TEST UNIT FOR 24 HOURS AND SUBJECTED TO NUMEROUS POWER UP AND POWER DOWN CYCLES, BOTH WITH AND WITHOUT AC CONNECTED. THE INTEGRATED POWER PAC AND THIS BACKUP BATTERY WERE ALLOWED TO BE EXHAUSTED WITH AC REMOVED AND FORCING AN AUTOMATIC SHUTDOWN. EXCEPT FOR THE ANTICIPATED BATTERY LOW ALARMS, NO BATTERY "FAILURE" ALARM WAS GENERATED.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE OF THE HT70 VENTILATOR, WHEN THE DEVICE WAS PLUGGED TO THE AC POWER SOURCE, A "BACK UP BATTERY FAILURE" ALARM WAS GENERATED. A MESSAGE INDICATING THE NEED OF INSPECTION WAS DISPLAYED BY THE CONDITION DIDN'T OCCUR ANY MORE, THE DEVICE WAS CONTINUOUSLY USED UNTIL AN ALTERNATE DEVICE WAS READY. 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
    570426 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention