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

Device Problem Defective Component (2292)

Patient Problem Anxiety (2328)

Event Type  Injury  

Event Description

I own a philips dreamstation bipap machine.Philips sent a replacement for the defective part last year and i replaced it.The current machine is working less predictably.But when i attempt to replace the machine i'm informed by medicare, and my insurer and my doctor and the supplier that i cannot purchase a new bipap machine because the fda has mandated that i pass a sleep test that i cannot possibly pass because i cannot sleep without a bipap machine.The fact that my machine is more than five years old and therefore due replacement is irrelevant to the fda.I've tried contacting the fda by phone but no one responds.When i leave a message with the fda, no one responds.When i attempt to determine the specific fda official responsible for withholding a bipap machine replacement, their identity is withheld by the fda.Up until now philips has provided me with a machine that has kept me living the past 16 years.Conversely the fda has abused its authority by preventing the acquisition of a new bipap machine.In other words, the fda actions threaten my life.Model, catalog, lot, serial, and udi numbers: i am blind and i cannot read.The apparent gross indifference by the fda has created needless anxiety.The fda, not philips, threatens my health and even my life.Thus far the fda exhibits complete indifference.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15094853
• MDR Text Key: 296596183
• Report Number: MW5111088
• Device Sequence Number: 2
• 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: 07/21/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CRESTOR ; PLAVIX
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 168 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White