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

Model Number DREAMSTATION AUTO CPAP DOM

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

I filed my paperwork for the recall of my philips cpap july 1, 2021.A year and three months later they still can't tell me when a replacement device will be shipped to me yet they advised me to cease using the device.Talking to a representative today, they first claimed that there is no shortage of devices and then claimed that they had no units to ship and no idea when they could replace my unit.Either the device is a useless medical treatment or, the company has recklessly endangered patients using their device.Either way, the fda should take immediate action against the company.Fda safety report id #(b)(4).

• Brand Name: PHILIPS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 15674509
• MDR Text Key: 302569733
• Report Number: MW5112873
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION AUTO CPAP DOM
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male