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

Model Number DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682); Chemical Problem (2893)

Patient Problems Pain (1994); Anxiety (2328); Cancer (3262); Solid Tumour (4552)

Event Date 05/14/2021

Event Type  Injury  

Event Description

I had a sore form on my lower right lip in (b)(6) 2021.I thought it was a fever blister but after several weeks the sore still had not healed.My wife eventually got me in to the dentist (b)(6).I was then sent to an oral surgeon (b)(6) on (b)(6) 2021 for a biopsy and removal of what was then thought to be a tumor.The biopsy came back as squamous cell carcinoma.I was then sent to see dr.(b)(6) at the department of oral and maxillofacial surgery located on (b)(6) on (b)(6) 2021 (phone # (b)(6)).After a physical examination and review of biopsy reports, dr.(b)(6) stated that a second surgery would be required to remove further areas of my lower lip that still contained squamous cell carcinoma.I was then scheduled for surgery #2 at (b)(6) to remove another portion of my lower right lip to eradicate rest of the cancer.This surgery was performed on (b)(6) 2021.On (b)(6) 2021, to my incredible disbelief, i received an urgent recall of my philips cpap (dreamstation) machine.The recall stated " the potential risks of chemical exposure due to off-gassing include but are not limited to: toxic and carcinogenic effects".The recall letter also stated to immediately discontinue use of this device.I have suffered extreme pain and suffering, anxiety, loss of financial income due to this product inflicting/causing squamous cell carcinoma to develop in my body.I have a follow-up appointment with dr.(b)(6) on (b)(6) 2021 to review/receive my continued medical care for this cancer.I have also endured loss of financial income and deteriorating decline in my respiratory system due to non use of my cpap machine which has been ordered by my physician (b)(6) to wear every night during sleep to prevent apnea and sudden respiratory arrest.Thank you, (b)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12648391
• MDR Text Key: 277144735
• Report Number: MW5104670
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025646
• UDI-Public: 00606959025646
• 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: 10/13/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 132