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

Model Number DREAMSTATION 2 ADVANCED

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2023

Event Type  malfunction  

Event Description

As part of the agreement between the fda and philips, i received a replacement cpap device from philips.The "new" device is considerably worse than the original device.They are trying to replace a real medical device with a pile of consumer electronics trash.They may perform the same function but it will not hold up over time.This is a disgrace to allow them to fleece their injured customers in this way.When discussed with philips, their suggestion on the cheapness of the device is that i can order new parts from the medical device company out of my pocket.This is clearly a money grab by supplying a device that is inferior to the replaced device while trying to keep the fda happy and not sue them.Don't believe me? check out the reviews on the dream station 2 here:(b)(6) reviews the dream station 2 has all the indicators of a rebranded oem device that is barely functional out of the box and little to inspire confidence in what should be a medical device.I hope that the fda checks into this and requires philips to disband this travesty of a recall replacement with an actual like for like replacement.They still manufacture and sell the dream station (1) so that is not a legitimate excuse.

• Brand Name: DREAMSTATION 2 ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16513098
• MDR Text Key: 311046623
• Report Number: MW5115588
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DREAMSTATION 2 ADVANCED
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White