BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED CPAP: S8 AUTO SET II H4I

    MDR report key: 1726758 · Received June 11, 2010

    Report

    Report Number
    MW5016357
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    RESMED CORP
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CPAP TYPE MEDICAL EQUIPMENT WITH HEATED HUMIDIFIERS LACK, AUTOMATIC SAFETY SHUT-OFF, POSSIBLY GENERAL CONDITION IN CPAP INDUSTRY. REGULAR HEATED HUMIDIFIERS, -NON-MEDICAL EQUIPMENT-, HAVE AN AUTOMATIC SAFETY SHUT-OFF. CONSEQUENCES IF CPAP UNIT RUNS OUT OF WATER, PT BECOMES UNCONSCIOUS, OR IF THE UNIT TURNS OVER WITH WATER IN IT? PT IS ATTACHED DIRECTLY TO THE CPAP EQUIPMENT BY A HEATED-HUMIDIFIED-AIR HOSE WHILE SLEEPING AND POSSIBLY TOSSING AND TURNING, EVEN GREATER POTENTIAL FOR AN EQUIPMENT TIP-OVER AND POSSIBILITY FOR SHORT CIRCUIT, FIRE, BURNS, OR ELECTROCUTION. BECAUSE OF MEDICAL/SLEEP ISSUES, THE PT MAY BE EVEN MORE VULNERABLE TO CATASTROPHIC CONSEQUENCES IN THE EVENT OF A CPAP ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED CPAP: S8 AUTO SET II H4I CPAP NHJ RESMED CORP
    2 RESMED CPAP: S9 H5I CPAP NHJ RESMED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR