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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS ELECTRONICS LTD DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number RESPIROTRONIC
Device Problem Output Problem (3005)
Patient Problems Muscle Weakness (1967); Pain (1994); Cancer (3262)
Event Date 04/30/2020
Event Type  malfunction  
Event Description
I never smoke or been in a hard full air quality early last year i started to feel weak and then having a pain under my right side medium rib's, i check with my medical provider and for 12 day i was taking pain pills and i was getting off the pain.Couple days later the pain came back same area, i talk to the dr.Office and i request a ct scan; or other tests to found out what was wrong the result showing a three spots in my right lung then after a endoscopy biopsy was enough i was get done a second biopsy by laparoscopic surgery and be in the hospital to recover the diagnosis was a small cell carcinomas stage 2 then my oncology dr request a pet scan and imr to check if the cancer was spread in other part of my body since then i start to take chemotherapy 21 days a part, and i been continuing with an immune therapy 21 days apart fda safety report id# (b)(4).
 
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Brand Name
DREAMSTATION
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS ELECTRONICS LTD
MDR Report Key13169958
MDR Text Key283393044
Report NumberMW5106470
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberRESPIROTRONIC
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/04/2022
Patient Sequence Number1
Patient Outcome(s) Other;
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