MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. HEATED HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problems Mechanical Problem (1384); Nonstandard Device (1420); Material Integrity Problem (2978); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Headache (1880); Discomfort (2330); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

I had been using a philips respironics remstar auto a-flex cpap from 8/5/2015 through 12/6/2019 when i began using philips respironics dreamstation.From day the dreamstation was noisy and uncomfortable to use.I returned to lincare a week later.The tech said the filters were very dirty and verified the equipment was noisier than it should be.She switched out the motor/blower section.It was still loud and the filters continued to have a lot of dark grey/black on them with each bi-monthly change.I just decided it must be the new machine.I continued using the machine but had difficulty sleeping due to the noise, occasional smell of chemical and skin irritation causing me to remove the mask.I also had the headache, upper airway irritation, chest pressure and sinus pressure as indicated in philips recall notice.I was prescribed sleeping pills for about 15 months due to decreased ability to get to and stay asleep.Once the sleeping pills were stopped, i was not able to sleep again.I would put on the cpap headgear with nasal pillows but would often have to remove them due to discomfort and noise.Many nights i was only able to tolerate the cpap for a few minutes to an hour or so.In early (b)(6), i called lincare again.The rep came to the house, again commented on the dirtier than normal filters and noise from the machine.At this point, she again changed out the cpap blower section.There was no change in performance and i didn't think i had any recourse.I tried to use the cpap each night but could rarely tolerate it for more than a few minutes (occasionally a few hours).On (b)(6) 2021, my husband shared an email with me from medicare stating there was a medical device recall from philips.I went to their website and my machine was listed as one that had been impacted.I completed the registration form.Luckily, i still have my 1st cpap and have begun to use it again.I use the same tubing, nasal pillows and head gear without the noise of discomfort.My concern is that many of the symptoms i just ignored as 'part of daily life' may actually, have been caused or exacerbated by my using the dreamstation machine(s) >20 months and these may cause some long-term harm.Thank you for your time and interest in this.(b)(6).Fda safety report id # (b)(4).

• Brand Name: HEATED HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12481086
• MDR Text Key: 272168377
• Report Number: MW5103987
• Device Sequence Number: 2
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR