BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1568417 · Received December 8, 2009

    Report

    Report Number
    2023050-2009-00045
    Event Type
    Other
    Date Received
    December 8, 2009
    Date of Event
    April 7, 2009
    Report Date
    December 7, 2009
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AFTER INVESTIGATION OF THE RETURNED VENTILATOR, THE REPORTED PROBLEM WITH LOW PRESSURE ALARM AND RED LIGHTS FLASHING COULD NOT BE DUPLICATED. THE VENTILATOR WAS SENT BACK TO ITS MFR. EVAL AT THE MFR SITE DID NOT FIND PROBLEMS ON THE RETURNED VENTILATOR AFTER RUNNING THE VENTILATOR FOR 72 HOURS. THE PROBLEM WAS MOST LIKELY OCCURRED DUE TO AN ESD INTERRUPTION WHICH EXCEEDED THE STANDARD LIMITS.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER THE SUCTIONING WAS DONE AND PLACING THE PT BACK ON THE VENTILATOR, THE VENTILATOR SHOWED ALL RED LIGHTS FLASHING AND GAVE A LOW PRESSURE ALARM. THE ALARM COULD NOT BE RESET AND THE LIGHTS KEPT FLASHING. THE PT WAS IMMEDIATELY MANUALLY VENTILATED AND THEN SWITCHED TO A BACKUP VENTILATOR. LATER, IN AN ATTEMPT TO SOLVE THE PROBLEM THE VENTILATOR WAS SHUT OFF AND TURNED BACK ON AND A "SERVICE NEEDED" MESSAGE WAS IN THE MONITORING WINDOW. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY OR DEATH IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention