MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Patient Problem Cancer (3262)

Event Date 07/28/2021

Event Type  Injury  

Event Description

Began using the philips dreamstation bipap auto sv sleep apnea machine on (b)(6) 2018.On (b)(6) 2021, i was diagnosed with squamous cell carcinoma on the vocal cords.Continue to use the machine as directed by philips and the fda during the interim period while awaiting a recalled replacement.On (b)(6) 2022, i received another cancer diagnosis, same vocal cord area.A total laryngectomy surgery was required; performed on (b)(6) 2023.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 17781776
• MDR Text Key: 323943315
• Report Number: MW5145920
• Device Sequence Number: 1
• Product Code: MNS
• 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: 09/14/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Patient Sequence Number: 1
• Treatment: PROBIOTIC; THYROXINE
• Patient Outcome(s): Disability; Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White