BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTART AUTO

    MDR report key: 4297231 · Received November 26, 2014

    Report

    Report Number
    MW5039367
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    November 22, 2014
    Report Date
    November 26, 2014
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NOTED THAT MY CPAP DEVICES HUMIDIFIER FUNCTION STOPPED WORKING. TOOK THE MAIN CONTROL UNIT APART AND NOTICED A BURNED/MELTED ELECTRICAL CONNECTION INSIDE THE DEVICE THAT PROVIDES POWER TO THE REMOVABLE HUMIDIFIER. I DO NOT KNOW THIS DAMAGE WAS CAUSED BY THE DETACHABLE HUMIDIFIER OR NOT. HUMIDIFIER INFO - PHILIP RESPIRONICS - REMSTAR (HEATED HUMIDIFIER) REF: 1056215, SN:(B)(4), REV .00 2010222. NOW THINKING BACK I MAY OF NOTICED SLIGHT BURNING PLASTIC ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767676 REMSTART AUTO REMSTART AUTO CBK PHILIPS RESPIRONICS 550P
    767677 HEATED HUMIDIFIER HEATED HUMIDIFIER BZD PHILIPS RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR