BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 18902354 · Received March 13, 2024

    Report

    Report Number
    MW5152820
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    March 11, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    MNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USING REPLACEMENT/REBUILT AUTOSV BI-PAP PHILLIPS AND NOTICED THAT FILTERS IN THE LAST MONTH ARE COMING OUT ALMOST BLACK WHEN REPLACING THE FILTERS ROUTINELY. NORMALLY, THE FILTER IS NOT NOTICEABLY DIRTY WHEN BEING REPLACED. THIS HAPPENED ON MY ORIGINAL SYSTEM AS WELL PRIOR TO REPLACEMENT WHERE THE REPLACEMENT FILTER WHICH IS CHANGED OUT BI-WEEKLY IS ALMOST BLACK FOR NO KNOWN CAUSE OR A CAUSE I CAN IDENTIFY WITH DOCTOR'S ASSISTANCE. BENIGN CRAMP FASCICULATION MUSCLE/NERVE DISORDER, OBSTRUCTED/CENTRAL SLEEP APNEA, HYPERSOMNIA, MORTON'S NEUROMA BOTH FEET, HIGH BLOOD PRESSURE. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266793 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILLIPS / RESPIRONICS INC. DSX900S11

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other ALSO, HAVE A SPINAL STIMULATOR FOR THE LAST YEAR.| APPLE VINEGAR.| ASPIRIN.| BACLOFEN.| CANDESARTAN.| CLONAZEPAM.| D-AMPHETAMINE.| FISH OIL. | GARLIC.| MAGNESIUM GLYCINATE.| MAGNESIUM MALATE, MAGNESIUM GLYCINATE, ZINC, FISH OIL, VITAMIN D, MULTI VITAMIN, MELATONIN, ASPIRIN, GARLIC, APPLE VINEGAR.| MELATONIN.| MULTI VITAMIN.| NABUMETON.| ROPINIROLE.| TOPIRAMATE.| VITAMIN D.| ZINC.