BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO M-SERIES

    MDR report key: 2820269 · Received October 31, 2012

    Report

    Report Number
    2518422-2012-02168
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K063830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4) ALLEGED THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) UNEXPECTEDLY STOPPED WORKING. WHEN THE PT AWOKE AND TRIED TO RESET THE DEVICE BY UNPLUGGING AND PLUGGING IN, THE PT ALLEGEDLY SAW SMOKE AND FLAMES. THE PT CLAIMS SHE UNPLUGGED THE DEVICE AGAIN AND THE FLAMES WERE EXTINGUISHED. THE CPAP, HUMIDIFIER AND ASSOCIATED POWER SUPPLY HAVE NOT YET BEEN RECEIVED BY THE MFR FOR CONFIRMATION AND EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR AUTO M-SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATORY) BZD RESPIRONICS INC. 500M

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR M-SERIES (DC) HEATED HUMIDIFIER: (B)(4),| (B)(4), 04/2009