BEUDAMED
    FDA Adverse Event Summary report: N

    PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP MACHINE

    MDR report key: 8491583 · Received April 5, 2019

    Report

    Report Number
    MW5085629
    Date Received
    April 5, 2019
    Report Date
    March 24, 2019
    Manufacturer
    RESPIRONICS, INC. / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    BZD
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LAST NIGHT MY PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP MACHINE STOPPED AND WOKE ME UP. AS I LOOKED AT THE MACHINE THERE WAS SMOKE COMING OUT OF THE MACHINE. THE SMOKE FILLED THE ROOM. THERE WERE BURN MARKS ON THE BOTTOM OF THE MACHINE AND IT WAS VERY HOT. DEVICE IS NO LONGER USABLE. RETAILER: (B)(6). RETAILER STATE: (B)(6). PURCHASE DATE: (B)(6) 2019. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282839 PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV DREAMSTATION AUTO CPAP MACHINE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR