MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION 2 BIPAP ASV; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX900T11C

Device Problem Nonstandard Device (1420)

Patient Problem Weight Changes (2607)

Event Date 08/07/2021

Event Type  Injury  

Event Description

Bipap asv recalled by philips respironics.Immediately stopped usage and registered device.Philips has been negligent in replacing my machine.I stopped using it for 9 months and incurred weight gain and other effects associated with sever complex sleep apnea.I have called on numerous occasions and have been read a script.I have tried through my insurance to get a new machine with a new prescription only to be denied by several dmes.I am going on 14 months now and had to re-continue use of the recalled device from advice from the va.Either i still use the device and risk cancer or stop using it and risk heart attack.I need help with this now.I have been more than patient but i feel i have been patient enough.Please provide some relief with this.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION 2 BIPAP ASV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15562897
• MDR Text Key: 301520614
• Report Number: MW5112491
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: B12; FLAXSEED ; MELOXICAM; METAMUCIL; MULTIVITAMIN; VIT D
• Patient Outcome(s): Disability; Life Threatening; Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White