BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP, RESPIRONICS REMSTAR, M-SERIES HEATED HUMIDIFIER-DOM

    MDR report key: 4916376 · Received July 9, 2015

    Report

    Report Number
    MW5044178
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    May 12, 2015
    Report Date
    June 26, 2015
    Manufacturer
    RESPIRONICS
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD A CPAP (RESPIRONICS, REMSTAR, M SERIES HEATED HUMIDIFIER-DOM, MODEL# 1051158. I WAS USING THE UNIT. I WOKE UP IN THE MORNING AND SMELLED THIS OBNOXIOUS ODOR. A ONE-INCH PLASTIC AT THE BOTTOM OF THE UNIT, JUST BELOW THE POWER SUPPLY CABLE ENTRANCE, HAD MELTED. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. DOCUMENT NUMBER: (B)(4), REPORT NUMBER:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444804 CPAP, RESPIRONICS REMSTAR, M-SERIES HEATED HUMIDIFIER-DOM NONE BZD RESPIRONICS 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR