BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3893603 · Received June 9, 2014

    Report

    Report Number
    2023050-2014-00235
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED HT70 CONTROL BOARD WAS INSTALLED INTO A TEST VENTILATOR. THE UNIT WAS POWERED UP AND RUN OVERNIGHT WITHOUT INCIDENT. THE UNIT WAS THEN POWER CYCLED AN ADDITIONAL TEN TIMES AND NO ERRORS WERE OBSERVED. THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    COVIDIEN PERSONNEL VISITED THE HOSPITAL TO RETRIEVE THE DEVICE. THE DEVICE HAD BEEN ISOLATED, BUT HE POWER CORD WAS USED FOR ANOTHER DEVICE DURING STORAGE. THE DEVICE WAS LEFT UNPLUGGED, AND THE BATTERY HAD BEEN DEPLETED. THE DEVICE WAS THEN CONNECTED TO ALTERNATING CURRENT (AC) POWER AND ALLOWED TO CHARGE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER IN (B)(6) STATING THAT DURING PATIENT USE FOT HE HT70 PLUS VENTILATOR, WHEN THE CIRCUIT WAS REMOVED FOR SUCTION, THE DEVICE WAS ON STANDBY MODE AND IT SHUT DOWN. IT WAS TURNED ON AGAIN BUT DIDN'T START UP. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO NEGATIVE PATIENT CONSEQUENCES REPORTED. FIVE DAYS LATER, AT THE HOSPITAL, THE DEVICE STARTED UP WHEN TURNED ON WHILE ON BATTERY POWER (SHOWED AS 0%); HOWEVER IT WENT TO THE STANDBY MODE AND SHUT DOWN. WHEN THE UNIT WAS TURNED ON WHILE BEING CONNECTED TO THE ALTERNATING CURRENT (A.C.), THE BATTERY STARTED CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334999 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention