MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS INC. SYSTEM ONE REMSTAR PRO CFLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problems Abdominal Pain (1685); Headache (1880); Hematoma (1884); Nausea (1970); Vertigo (2134); Vomiting (2144); Obstruction/Occlusion (2422); Lymphoma (3263)

Event Date 12/28/2018

Event Type  Injury  

Event Description

I used a respironics system one remstar pro flex+ cpap sn (b)(4) in (b)(6) 2012 for sleep apnea with daytime sleepiness and used it continuously 7-8 hrs/d until around (b)(6)2019 when i asked for a new device because it was making too much noise.I received a respironics dreamstation one auto cpap sn (b)(4) around (b)(6) 2019 and used this continuously 7-8 hrs/d through (b)(6) 2020 when i obtained a new dreamstation one due to change in insurance sn (b)(4) again used continuously until respironics issued a recall on 6/14/2021.I developed intermittent abdominal pain around (b)(6) 2019 and symptoms of intermittent small bowel obstruction around (b)(6) 2019.I was hospitalized twice for this, the second time undergoing exploratory laparotomy on (b)(6) 2019 with bowel resection with finding of stage iies diffuse large b-cell lymphoma.I required treatment with 6 cycles of immunochemotherapy with r-chop, resulting in complete remission.My course was complicated by: an infected sublingual hematoma with neutropenia, migratory superficial thrombophlebitis, dyspnea due to deconditioning (extensive workup required), drop attacks, nausea, vomiting, vertigo and headaches due to exacerbation of meniere's disease with tumarkin's crisis.The last required treatment with intra-auricular steroids and gentamicin and eventually a left labyrinthectomy on (b)(6) 2020, with resulting deafness of left ear and gait imbalance.I also had recurrent small bowel obstruction from my original surgery requiring lysis of adhesions on (b)(6) 2020.All this lead to long-term disability from work.I eventually was only able to return to work per diem in (b)(6) 2020 and retired about 5 years earlier than planned in (b)(6) 2020.Once i read about the respironics recall, i stopped using the device and obtained a cpap device from a different manufacturer (resmed) out of concern that the gas that has been reported to leak from the foam and known to be carcinogenic may have caused my lymphoma.Fda safety report id # (b)(4).

• Brand Name: SYSTEM ONE REMSTAR PRO CFLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 12099257
• MDR Text Key: 259679653
• Report Number: MW5102218
• Device Sequence Number: 2
• 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: 06/26/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 65 YR
• Patient Weight: 75