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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS INC. PHILIPS SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

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PHILIPS RESPIRONICS / RESPIRONICS INC. PHILIPS SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Pneumonia (2011); Dizziness (2194); Ambulation Difficulties (2544); Weight Changes (2607); Constipation (3274); Unspecified Heart Problem (4454); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/28/2022
Event Type  Injury  
Event Description
Hi, my name is (b)(6).My mother (b)(6) was using a cpap machine for about 9 or 10 years, i just recently found out that the device was on recall, my mother was hospitalized in late (b)(6) because of dizziness, she had pneumonia they said which has been a recurring thing for years now, and then she was told she needed a heart surgery so the pulmonologist asked me to bring her cpap machine in to the hospital, i assumed for her to sleep with at night, a few hours after i brought the device in i came back and she had told me they found masses in her lungs and there wasn't going to be any surgery.So she came home on (b)(6) 2022, and continued to use the device ad we were still clueless about a recall, there wasn't an actual diagnosis on the discharge papers so we followed up in 15 days with her primary care physician who said the systems were down and we would have to wait to see the results and that no one can make a diagnosis without him because of her insurance plan type.I was not aware as i just met the doctor for the first time since moving here to (b)(6) in 2019 but i thought it seemed fair enough that he said he would need 6 weeks for her lungs to clear up from pneumonia to take imaging even though the hospital did theirs, 6 weeks later we went back and he still didn't have results and then told us they are just concerned that she has recurring pneumonia.He was like walking into walls and seemed lost! i pressed him about the heart and lung issue that was mentioned a few months earlier, as he read down the page a little there was her diagnosis, he breezed through it fast so i had to ask him to repeat it, he was very vague, never scheduling a visit for her with the pulmonologist or cardiologist.I took her back there on (b)(6) 2023 still not knowing the diagnosis from (b)(6) 2022 hospital stay, there was a fill in physician on (b)(6) 2023 who went next door and got us a visit right away with the pulmonologist, he told her she has 6 months to live, and then said to bring that cpap in cause it's a "dinosaur" (his words) i said oh no doc! is it safe? he said "oh yeah that thing is a workhorse" still not mentioning any sort of recall at all, and we still had no idea there had been one.By now she was in a wheel chair and was down 120 pounds and they never seemed concerned or mentioned the weight loss except agreeing when we mentioned it.I eventually heard by word of mouth about recalls on those devices because i was starting to get concerned with the fact she wasn't receiving anymore parts and all of her symptoms.I now have her in hospice care in my house.She can barely walk barely a bite or so of food a day, and no bowel movements, and she's now like a child, as death is certain and very near we are concerned with the health care she was receiving and the risky treatments.Her pulmonologist sent her a letter last week stating that she needs to find a new pulmonologist.I am emotionally broken over this treatment of my mother and the lack of compassion and humanity for her, they have screened her many times for depression and they know she has psychological issues that needed care not abuse.She was living alone for the last 15 years after losing my father shortly after moving to (b)(6), my wife and i were finally able to leave our home state and move to (b)(6) to help her out.I had no idea what was to come.Philips has responded with a replacement device or 50 dollars, i have called (b)(6) and voiced my concerns and filed a complaint.Still have not received an answer or acknowledgement of anything.I'm completely broken over this and doing my best to care for my dying mother while our lives crumble around us just barely holding on.There is a lot more information tied to this story i know it may seem jumbled, i am available anytime and thank you for reading and for any help or advice you can offer.(b)(6).
 
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Brand Name
PHILIPS SYSTEM ONE
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
PHILIPS RESPIRONICS / RESPIRONICS INC.
MDR Report Key16940735
MDR Text Key315416463
Report NumberMW5117569
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/15/2023
Patient Sequence Number1
Treatment
LACTULOSE; LORAZEPAM ; METOPROLOL ; MORPHINE ; PREDNISONE ; SENNA PLUS
Patient Outcome(s) Hospitalization; Disability;
Patient Age76 YR
Patient SexFemale
Patient Weight57 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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