MAUDE Adverse Event Report: PHILLIPS RESPIRONICS DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 100600C OR 100605C

Device Problems Component Missing (2306); Data Problem (3196)

Patient Problem Fatigue (1849)

Event Date 06/01/2017

Event Type  Injury  

Event Description

I am being treated for severe sleep apnea.Not that i think it is relevant, however, i recently came off the medication abilify.However, two weeks approximately i started feeling sleepy during the day.I contacted my doctor, dr.(b)(6), and he refused to increase my percentage on my cpap machine, recommended the possibility of getting on medication, and required me to test in other areas first, which i had my family doctor do.Please note my family doctor stated that dr.(b)(6) should have ordered a blood count test because of my symptoms.Since he didn't, my family ordered it.All tests came back fine, which included an allergy test, iron level check test, and a test to check for anemia.When i called back to dr.(b)(6) office i explained all the tests came back fine.Dr.(b)(6) tried calling two times yesterday in which i was unable to answer the phone.I tried calling back that number he called me on several times and it was always "busy".Finally, he called me this morning and agreed to increase the percentage to 14 percent.However, i am experiencing a problem with the cpap machine downloading the information so i can use the new increase.Dr.(b)(6) and other individuals have tried to explain to me that the cpap machine could tell if my sleep apnea is worsening or not.I disagree.The mask and tubing does not have any sensors.I have an inquiry into the (b)(4) as well regarding that machine from the manufacturer.In addition to feeling sleepy during the day i have also began not feeling refreshed when i awake.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 6650214
• MDR Text Key: 77943474
• Report Number: MW5070484
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 100600C OR 100605C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 45 YR
• Patient Weight: 193