BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED S8 SERIES

    MDR report key: 2222023 · Received August 18, 2011

    Report

    Report Number
    MW5021816
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    RESMED INC
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE MFR RESMED, INC: THEIR S8 SERIES OF CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICES ARE NOT ALWAYS CONTINUOUS. THEY OFFER A SETTING CALLED EPR (EXPIRATORY PRESSURE RELIEF) WHICH DROPS THE PRESCRIBED PRESSURE DURING EXHALATION. THIS EPR PRESSURE SWING CAN BE ON THE ORDER OF 1 TO 3 CM/H2O. THE RATIONALE FOR THIS DROP IN PRESSURE IS TO SUPPOSEDLY MAKE THE PT MORE COMFORTABLE, BUT BREATHING OUT AGAINST LOWER PRESSURE. THE COUNTERBALANCING LOGIC IS THAT IT IS AT THE END OF EXPIRATORY PHASE WHERE THE AIRWAY CLOSE DURING OBSTRUCTIVE SLEEP APNEA. SO, IN EFFECT, MY SLEEP APNEA IS NOT BEING TREATED PROPERLY (NON-DELIVERY OF PRESCRIBED PRESSURE) WHEN THE SUPPOSED NON-THERAPEUTIC EPR CONTROL IS USED, YET. THERE ARE MANY REPORTS OF HAVING OBJECTIVE RECORDINGS OF HIGHER APNEAS AND HYPOPNEAS WHEN THE EPR IS USED, AND IT SEEMS TO FOLLOW A DOSE DEPENDENT CURVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED S8 SERIES CPAP BZD RESMED INC S8 SERIES ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Congenital Anomaly| H| L| O| R| S