MAUDE Adverse Event Report: PHILIPS/RESPIRONICS INC. DREAMSTATION BIPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Cancer (3262); Swollen Lymph Nodes/Glands (4432)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Have been on philips bipap machine for years.Notified of recall of dreamstation machine in 2021.Took 2 years, 4 months to get a new machine.Dr.(b)(6) at (b)(6) medical center confirmed a swollen lymph node in neck area.During visit scoped the throat and found a small tumor on left tonsil.Confirmed later with needle biopsy on (b)(6) 2023 and followed by mri on (b)(6) 2023 then ultrasound fine-needle aspiration biopsy (b)(6) 2023, findings squamous cell carcinoma.Next was ct-pet scan on (b)(6) 2023, confirming the biopsies and no additional cancers noted at this time but 2 nodules were noted in left lung.Referred to (b)(6) for consultation for robotic surgery on neck.Dr.(b)(6) did biopsy in office on (b)(6) 2024 and results were inconclusive as tissue used was "devitalized cells" robotic surgery not recommended as could not guarantee all tumor could not be reached.Referral back to (b)(6) for radiation treatment, not scheduled at this time.Next appointment with ent dr.(b)(6) is monday, (b)(6).

• Brand Name: DREAMSTATION BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 18941365
• MDR Text Key: 338258191
• Report Number: MW5153006
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• 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: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White