BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 5328546 · Received December 27, 2015

    Report

    Report Number
    2023050-2015-00406
    Event Type
    Injury
    Date Received
    December 27, 2015
    Report Date
    December 4, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTILATOR WAS RETURNED FOR EVALUATION. THE SERVICE ENGINEER EVALUATED THE DEVICE AND COULD NOT VERIFY THE REPORTED COMPLAINT. WHEN THE VENTILATOR WAS POWERED ON, THE DISPLAY SCREEN WAS BLACK AND THE DEVICE FAILED THE POWER ON SELF-TEST (POST). THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB) WAS REMOVED AND VISUALLY INSPECTED. A BROKEN COMPONENT WAS FOUND. DURING INSPECTION, A SCRATCH IN THE DISPLAY SCREEN WAS ALSO FOUND, WHICH MAY CAUSE POST ISSUES. THE SBC PCB AND THE DISPLAY WERE REPLACED. THE DEVICE PASSED ALL TESTING. THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTILATOR WAS RECEIVED FOR EVALUATION AND REPAIR. THE DISPLAY REMAINED BLANK AFTER POWER CYCLING, AND FAILED POWER ON SELF-TEST (POST). THE SERVICE ENGINEER (SE) REPLACED THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AS IT WAS FOUND TO HAVE SCRATCHES. THE CUSTOMER REPORTED COMPLAINT WAS VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING PATIENT USE AND TRANSPORTATION, THE VENTILATOR FROZE AND COULD NOT BE SHUT DOWN. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852840 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention