BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 2932319 · Received January 22, 2013

    Report

    Report Number
    2023050-2013-00046
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 14, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED VENTILATOR WAS VISUALLY INSPECTED AND FOUND THAT THE FACE PLATE OF THE FLOW SENSOR RECEPTACLE WAS MISSING. DURING THE FUNCTIONAL TEST, IT WAS OBSERVED THAT THE VENTILATOR FUNCTIONED NORMALLY; HOWEVER, LCD SCREEN WAS UNRESPONSIVE WHEN IT WAS TOUCHED CONFIRMING THE REPORTED ISSUE. THE VENTILATOR WAS CYCLED ON AND OFF MULTIPLE TIMES AND THE TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE. DYNAMIC SIGNAL PROBING OF THE SINGLE BOARD COMPUTER FOUND THAT THE RESET PIN WAS AT A RANDOM STATE AT THE TIME THE BOARD WAS POWERED UP RESULTING IN THE LOCKING OF THE LCD TOUCH SCREEN. THE TOUCH SCREEN ISSUE WAS CORRECTED WITH A SOFTWARE CHANGE THAT INITIALIZED THE RESET SIGNAL TO THE PROPER STATE AT POWER UP, ENABLING THE TOUCH SCREEN CONTROLLER TO FUNCTION PROPERLY. THE VENTILATOR WILL BE RETURNED TO THE CUSTOMER AFTER REPAIR.

    Description of Event or Problem · 1

    REPORTEDLY, WHEN BOOTING UP, THE VENTILATOR WOULD FREEZE INTERMITTENTLY. THE SCREEN BECAME NON RESPONSIVE. THE VENTILATOR WAS TURNED OFF AND BACK ON AGAIN; HOWEVER, THE SCREEN ISSUE COULD NOT BE SOLVED. THERE WAS NO PT INVOLVEMENT REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31472 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1