BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 5218168 · Received November 11, 2015

    Report

    Report Number
    2023050-2015-00326
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 14, 2015
    Report Date
    December 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), THE TOP MEMBRANE AND THE PUMP WERE REPLACED. THE DEVICE PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR. THE UNIT WAS POWER CYCLED ON AND OFF TWENTY TIMES, AND NO ERRORS OCCURRED. THIS ERROR MESSAGE IS INTERMITTENT AND IS A KNOWN SOFTWARE RELATED ISSUE. THE SILENCE/ALARM RESET KEY WAS OBSERVED NOT HAVING SUFFICIENT RETURN CONTACT WHEN PRESSED. THE SE RECOMMENDED REPLACING THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), THE TOP MEMBRANE, AND THE PUMP. THE REPAIR HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO INTERFACE BETWEEN THE DEVICE AND THE FAILED COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, A VENTILATOR GENERATED AUDIO AND VISUAL ALARMS, AND DID NOT STOP BEEPING, EVEN WHEN UNPLUGGED AND THE BATTERY REMOVED. ALTHOUGH THE VENTILATOR CONTINUED CYCLING, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748486 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention