BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS REMSTAR PLUS M SERIES

    MDR report key: 1431520 · Received July 23, 2009

    Report

    Report Number
    MW5012211
    Event Type
    Injury
    Date Received
    July 23, 2009
    Date of Event
    July 23, 2009
    Report Date
    July 23, 2009
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A RESPIRONICS CPAP VENTILATOR UNIT, MODEL 1051158, SUPPLIED WITH AN INTEGRAL RESPIRONICS M-SERIES HEATED HUMIDIFIER, TO TREAT MY OBSTRUCTIVE SLEEP APNEA CONDITION. AT ABOUT 2AM IN 2009, THIS CPAP VENTILATOR UNIT STARTED TO FUNCTION ERRATICALLY AND SHUT DOWN AND ALSO CAUSED A VERY STRONG ODOR OF OVERHEATED OR SHORTED ELECTRICAL COMPONENTS IN THE OUTPUT AIR FLOW. THE ODOR IS STILL PRESENT INSIDE THE HEATED HUMIDIFIER CHAMBER OF THE UNIT AFTER AWAKENING. AT THE TIME OF FAILURE, THIS CPAP VENTILATOR STOPPED PROVIDING MEDICALLY NECESSARY AIRWAY VENTILATION AND THE PRESSURIZATION NEEDED TO MANAGE MY OBSTRUCTIVE SLEEP APNEA. I HAD TO UNPLUG IT TO PREVENT FURTHER RISK OF FIRE OR ELECTRICAL HAZARDS. I CONTACTED THE LOCAL SUPPLIER THE SAME DAY, AND THEY ARRANGED FOR ME TO RECEIVE A REPLACEMENT UNIT FROM RESPIRONICS THE NEXT DAY FOR A SIMILAR VENTILATOR UNIT MADE BY RESPIRONICS. IT IS UNCLEAR IF THIS RECALL IS RELATED TO MY SPECIFIC CPAP UNIT. I HAVE NOT BEEN NOTIFIED BY COMPANIES THAT MY CPAP UNIT HAS BEEN RECALLED. DATES OF USE: 2008 - 2009. DIAGNOSIS OR REASON FOR USE: OBSTRUCTIVE SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS REMSTAR PLUS M SERIES CPAP VENTILATOR DEVICE BZD RESPIRONICS CALIFORNIA, INC. 1051158
    2 M SERIES HEATED CPAP VENTILATOR DEVICE BZD RESPIRONICS CALIFORNIA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| O| S