BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 6017602 · Received October 11, 2016

    Report

    Report Number
    2023050-2016-00621
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 14, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE, SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND THE REPAIR COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ADDED PRODUCT ANALYSIS RESULTS. EVALUATION CODES PER COMPLETION OF INVESTIGATION CORRECTION: CORRECTED PMA/510K. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE VENTILATOR GENERATED A CONSTANT ALARM AND WOULD NOT SHUT DOWN. THE PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ALTHOUGH MEDTRONIC WAS NOT AUTHORIZED TO REPAIR THE DEVICE, THE CUSTOMER RETURNED THE HT70 CONTROL PRINTED CIRCUIT BOARD (PCB). THE CONTROL PCB WAS DIRECTED TO MEDTRONIC¿S PRODUCT ANALYSIS LABORATORY. VISUAL INSPECTION OF THE COMPONENT WAS CONDUCTED AND NO ANOMALIES WERE FOUND. AN INVESTIGATION WAS PERFORMED; HOWEVER, THE REPORTED ISSUE COULD NOT BE DUPLICATED. NO FAULT WAS FOUND WITH THE RETURNED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669152 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention