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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problem Cancer (3262)
Event Date 06/06/2020
Event Type  Injury  
Event Description
Black spots were noticed on a silicone seal in my almost-five-year-old respironics dreamstation auto cpap machine.I thought it was black mold, but i couldn't remove it with light pressure from a qtip.The spots were located on the corners of the silicone seal on the underside of the humidifier.After i got a new dreamstation cpap machine (b)(6) 2021, i pulled off the silicone seal from the old cpap machine and washed it with baby shampoo and water, and it eventually the black spots were removed.I still have this old cpap machine and kept it as a backup machine.In (b)(6) 2021 i was newly diagnosed with a rare form of blood cancer, polycythemia vera, by a hematologist oncologist at the (b)(6).Jak2 test ordered by a different doctor the latter part of 2020, and he referred me to the hematologist who diagnosed polycythemia vera.I'm giving approximate month and day dates as i'd have to look later for the exact date of the lab result, or exact day i saw the hematologist.Fda safety report id # (b)(4).
 
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Brand Name
DREAMSTATION AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
MDR Report Key12172999
MDR Text Key261905243
Report NumberMW5102535
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age68 YR
Patient Weight95
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