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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Pressure Problem (3012)

Patient Problem Apnea (1720)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

My original philips respironics cpap was recalled.This problem concerns the philips replacement device.I received my replacement device ((s/n (b)(6)) and tried using it on (b)(6) 2023.It would turn on and blow air prior to my mask being put on, but once i put on the mask and tried breathing through it the air pressure would immediately drop to zero.It would take an extreme amount of breathing effort to get the machine to blow air again, but after each breath the machine would again go to zero pressure.Philips was notified of the problem on (b)(6) 2023.To date i have received nothing in writing acknowledging the replacement machine's defectiveness or their interest in replacing it.Their customer support lines are complicated and cumbersome, and always require long wait times on hold, usually between 30-45 minutes.The agent i spent the most time with was able to read from a script but could not answer some basic questions.I would have summarized the info below but your website says to provide as much detail as possible.Here are my chronological notes from the calls to philips to try to correct the problem.(b)(6) 2023 ¿ returned home from vacation, setup replacement cpap including transferring data card to new machine, returned old cpap as instructed.New cpap does not work properly.It supplies air with pressure but is not properly sensitive to my breathing pattern so air pressure fluctuates with each breath and cuts out entirely between breaths, which ends up feeling like it's sucking the breath out of me.Called philips and was eventually told the problem is that the air pressure settings need to be changed (i don't think this is correct because the settings data should have been on the data card that i transferred but i'm going along with it).Philips said to call (b)(4) to get the name of a local provider who can unlock the device and change the settings.I got three names and numbers but none of them said they could help because i'm not a physician.(b)(6) 2023 ¿ called cpap.Com (where i purchased the original machine) and they sent me a youtube video link on how to access the settings.After watching the video i was able to access the settings, however they were found to be already set to the proper upper and lower limits, so now it's back to phillips! (b)(6) 2023 ¿ called philips at (b)(4).The woman who eventually answered was pleasant and eventually transferred me to the "replacement line" at (b)(4).Was on hold for hours and ended up speaking to someone who wasn't very competent.She wasted my time for an hour as she read from an instruction sheet without (a) first even asking for specific information about the machine's failure or (b) understanding some of the terms on her sheet.Finally, after being unable to answer some basic questions, she said she'd call me back after she "checked further".I was given a ticket reference number, if you need it.Later today she called back and asked me to plug in my device to a different electrical outlet and see if it worked, but of course it didn't make any difference.She never really asked me what the problem was but she could hear the air blowing thru the tube and thought the problem was solved and started to end the call until i interrupted her "good-bye" script and asked her to listen more carefully: that the machine doesn't work properly, that the pressure drops off as soon as i put on the mask, and that it feels like i'm going to choke or pass out.She asked some seemingly unimportant questions and then said that she's going to order a replacement device.It'll be sent after another department reviews her notes.Someone will get back to me or i can call this number for an update: (b)(4) on 3.(b)(6) 20233 - called for an update (b)(4) yesterday but got a recording that they're only open during normal business hours of m-f 8am to 5pm eastern time.Called today at exactly 4:32pm eastern time and got the same recording.I am a patient and user without resources to conduct the above tests.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17186233
• MDR Text Key: 317876974
• Report Number: MW5118708
• Device Sequence Number: 1
• 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
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLEGRA-D.; ALLOPURINOL 300MG.; LOSARTAN 50MG.; NAPROXEN SODIUM.; ROSUVASTATIN 5MG.; VITAMIN D3.
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White