MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION

Device Problems Defective Device (2588); Device Sensing Problem (2917); Pressure Problem (3012)

Patient Problem Discomfort (2330)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

To clarify one point, i am a physician.However, i am reporting as a pt because i was the pt in this case.I began using a respironics "dreamstation" cpap machine in (b)(6) 2019, set to the auto cpap mode with an initial pressure range of 5 to 15 cm h2o.At some point, i noticed that the pressures were high much of the time.This created a problem with increasing mask leak and poor sleep due to discomfort from the higher pressures.In (b)(6) 2020, i realized the problem: a defective machine.On the night of (b)(6) 2020, i was lying in bed, fully awake, with the mask on, and i noted the pressure on the machine increasing from 5 to 10 then to 15 as i lay there awake, breathing normally.Over the next few days, i tried several maneuvers to test the machine.For example, i unplugged it, plugged it back in to reset it, and then i sat upright with the mask on, breathing normally.The pressure increased over 5 or 10 mins.I also confirmed similar machine performance on data uploaded from the machine to oscar software on my pc; it appeared to be sensing multiple vibratory snores while i was sitting up awake.I brought the machine to my dme provider, who confirmed that it was broken.I have had no problems with the replacement machine over the last two weeks.Of note, my dme provider recently informed me that she fitted another stent with a new machine, and, in her words, "i had another machine, brand new out off the box, increasing the pressure as we were sitting in the office." you could contact my provider, (b)(6) for info about the other machine.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 5/14/2020 for report mw5092715.This is a follow-up to a report i filed on approximately january 30, 2020.I received a phone call from a staff member of respironics in response to this report.She informed me that respironics is aware of a "very rare" problem like the one i reported, in which the machine incorrectly senses vibratory snores and increases the pressure.I asked her if they were informing providers of the issues and she said no.I asked for follow up from respironics.The primary feedback was an email sent to my dme provider, which she forwarded to me: "this device was originally under ra (b)(4) which was to go to the product investigation lab with a complaint of vibratory snore due to the fda medwatch received by us which was originally created by your patient.Then another complaint was emailed in by you on the same day for "service required" on this device and the humidifier ra (b)(4), so it went to regular service and they reset the device.So no investigation can be performed, no customer letter can be provided as well.I apologize for the mix up, unfortunately the duplicate ra's for the same device caused the issue.This is a rare issue, sometimes caused by non-respironics filters.The engineers did review the other device you sent in as well, confirming your complaint.I apologize for any inconvenience this may have caused." respironics gave me a new machine, but i am now experiencing the same problem with the replacement machine.I took a video showing the pressure increasing; an upload showed that the machine was detecting frequent vibratory snores and, presumably, increasing pressure in response to that.(i was not snoring while filming the video.) i am working with my dme provider to get another replacement.We now know of three machines with this problem.As a physician, my concern is that these defect is occurring frequently.It is not an obvious defect when it occurs but - when not recognized - could substantially reduce patient compliance with cpap, jeopardizing their health.I am surprised that the manufacturer has neither notified providers nor, to my knowledge, initiated a recall.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 10/18/2022 for mw5092715.I am writing to report a safety issue with philips respironics cpap machines.This is not one of the safety issues that have led to the three active recalls on respironics machines, but an additional concern that also puts patients at risk.I reported on two machine failures previously, in report id (b)(4) on 5/12/2020 and in a report on 1/30/2020.This communication reports on additional instances of this machine defect.In its response letter for the 5/12/2020 report, respironics confirmed that they had received similar reports in the past.They claimed that it is not associated with a safety risk to patients.In fact, this defect poses a significant safety risk.The defect causes large variations in cpap pressure and unnecessarily high pressures, creating discomfort that may lead patients to abandon cpap therapy­ putting them at risk for all the complications of untreated sleep apnea.Because of our concerns about this unrecognized defect, a colleague and i published the attached article in the medical literature, reporting on four machine failures in three patients.Since its publication, we have learned of additional patients who experienced this machine failure.The volume of cases that we are uncovering makes it difficult to file form 3500 for each individual case.I hope that this letter and the accompanying article will lead to further investigation by the fda.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 9665258
• MDR Text Key: 178002644
• Report Number: MW5092715
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION
• Device Catalogue Number: INFO AVAILABLE FROM SLEEP TECH
• Device Lot Number: 2019-12-10 REV00
• Patient Sequence Number: 1
• Treatment: OTHER MEDICATIONS AVAILABLE ON REQUEST BUT NOT RELEVANT TO THIS REPORT.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White