BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 6491351 · Received April 13, 2017

    Report

    Report Number
    2023050-2017-05156
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 17, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510 (K) # CHANGED TO K090888,DEVICE EVALUATION: THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO MEDTRONIC¿S PRODUCT ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED CONDITION WAS DUPLICATED. THE CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A SOFTWARE PROBLEM ON THE SBC PCB. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HT70 VENTILATOR'S SCREEN FROZE AT POWER ON. THE DEVICE COULD NOT BE SHUT DOWN BY PRESSING THE POWER SOURCE BUTTON UNTIL THE SECOND TRY OF LONG PRESSING. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S SCREEN FROZE AT POWER ON. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272741 HT70 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1