BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1564741 · Received November 24, 2009

    Report

    Report Number
    2023050-2009-00044
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    February 9, 2009
    Report Date
    November 12, 2009
    Manufacturer
    NEWPORT MED INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Removal / Correction Number
    Z-1192-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE RETURNED VENTILATOR WAS PERFORMED BY TESTING VENTILATION AT STANDARD TEST SETTINGS. THE VENTILATOR INITIATED SHUTDOWN ALARMS WITHIN 1 MINUTE AND THE MESSAGE WINDOW SHOWED 10V SHUTDOWN DEVICE ALERT AND THE BUZZER GAVE A CONSTANT LOUD BEEPING SOUND. THE VENTILATOR WAS THEN PLUGGED INTO AC POWER AND ALLOWED TO CHARGE THE INTERNAL BATTERY FOR OVER 10 HOURS. THIRTY SECONDS AFTER STARTING VENTILATION, THE LOW BATTERY ALARM SOUNDED AND THEN THE VENTILATOR SHUT DOWN. REMOVED BATTERY FROM UNIT AND TRIED IN KNOWN GOOD VENTILATOR, AND THE SAME PROBLEM REPEATED. REPLACED THIS BATTERY WITH THE DUAL PAC BATTERY SYSTEM AND NO FURTHER ISSUES OCCURRED. PLEASE NOTE THAT ACCORDING TO THE MFR'S OPERATING MANUAL OF THE HT50 MODEL, THE INTERNAL BATTERY SHOULD BE REPLACED YEARLY OR WHEN THE BATTERY NO LONGER MEETS THE NEEDS OF THE USER. PLEASE ALSO NOTE THAT THIS IS A KNOWN ISSUE AND IN RESPONSE AN IMPORTANT MEDICAL DEVICE CORRECTION LETTER WAS ISSUED ON SEPT 14, 2007 AS A SHORT TERM FIX. NEWPORT MEDICAL HAS SINCE SUBMITTED A LONG TERM CORRECTIVE ACTION AS A SUPPLEMENT (THE DUAL PAC INTERNAL BATTERY SYSTEM) TO ITS 510K WHICH THE FDA HAS CLEARED IN DEC 2008. CONCLUSION:

    Description of Event or Problem · 1

    EVALUATION OF THE RETURNED VENTILATOR RESULTED IN THE VENTILATOR SOUNDING AN AUDIBLE LOW BATTERY ALARM, THEN SHUTTING DOWN AFTER 30 SECONDS. THIS OCCURRED AFTER THE VENTILATOR HAD THE INTERNAL BATTERY FULLY CHARGED FOR MORE THAN 10 HOURS. IF THIS WERE TO RECUR, IT COULD CONTRIBUTE OR CAUSE A SERIOUS INJURY GIVEN THE FACT THAT THE USER WOULD NOT HAVE ENOUGH TIME TO REACT BEFORE THE VENTILATOR SHUT DOWN. NOTE: THIS OCCURRED IN A LAB SETTING AND NOT DURING PT USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention