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

Model Number U/K

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Adult Respiratory Distress Syndrome (1696); Sleep Dysfunction (2517); Cough (4457)

Event Date 10/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020; i have a problem with my cpap machine.I was either wet in the morning or tank ran dry.I spoke to respiratory and she said it is older but let's replace tank and all tubing.I noticed i couldn't get my card out and used needle nose pliers.I didn't notice a difference and ever morning woke up with a barking cough, wet and tank empty.They said there was not anything they could do because i was not due until (b)(6) 2021.So i used it, throat and cough became chronic and was wet.I had been hospitalized several times due to pulmonary distress.I put tube socks on tubing which helped.I was not sleeping well.In (b)(6), i got a new card and was able to get it in and out.Prior to that it was stuck in machine.Then just as i thought i could manage 6 months, i got recall notice.I was advised not to use it as i have had cancer 3 years ago and my lupus had flared.As i was packing it up, i was stunned to see black mold.I clean my machine with vinegar and change filter but never looked at this part of machine.It sure answered the questions of why have i developed asthma, reactive airway disease and chronic sore throat.I cough for 30 minutes when i rise in am often starting day with nebulizer.The customer service at philips stated between carcinogens and black mold she understood why breathing became an issue.She stated put gloves on and a mask and put machine in bag.When they knew what they were going to be doing with fixing or replacing the recalled machines which mine was one of i would get a letter.I have had an extremely difficult time for the last month with sleep and i also have cardiac issues, hbp and moderate severe sleep apnea and i have not been able to sleep.The issue that i am bringing forward is my machine has black mold growing in it and that has got nothing to do with the recall and because of black mold i should have it replaced whether it's 2 years 3 years or 5 years not what they're telling me.There is nothing i can do, but phillip's disagrees because the black mold is as serious as or even more serious than carcinogens.Philips informed me that my machine should be replaced because of mold issue.They don't expect anything to happen with replacement of the machine because they put me on high priority due to the black mold until 6 to 8 weeks from now.So there are two issues one is it is recalled which i understand you have to go through that process.However my machine has black mold on it and i should not have to go through the recall process and should immediately been provided we with a new machine because she told me it was very dangerous to be breathing black mold.Do my lungs ever heal? what permanent damage has the black mold caused.I use symbicort and 2 different nebulizers.It destroyed my teeth; 7 months ago my teeth were great.I practice super dental hygiene.That is gone for ever.A tooth broke and i had 16 cavities.I am (b)(6) and never had one, so that should say something.The tooth that broke is my front tooth.Talk about being grateful for masks.Between breathing black mold in every night, losing my teeth, taking 3 medications have pulmonary distress and was taken to hospital and bp uncontrolled my cpap has caused numerous medical and preventable conditions.It all falls together on a time line.I must have accidentally clicked it.I am so sorry.Mind you my breathing is so poor, i might as well be.Fda safety report id# (b)(4).

• Brand Name: PHILLIPS RESTMORE CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS INC.
• MDR Report Key: 12266542
• MDR Text Key: 264944281
• Report Number: MW5102927
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2021
• Device Model Number: U/K
• Device Catalogue Number: U/K
• Device Lot Number: U/K
• 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): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 96