MAUDE Adverse Event Report: RESPIRONICS INC. DREAM STATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500S11F

Device Problems Contamination (1120); Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

I have a recalled philips respironics cpap machine.The first replacement device i received was filthy.It looked like it had been used in lieu of a plate.I sent it back.The second replacement device was cleaner but still didn't look like the exterior had been wiped down, let alone sanitized.In addition there were tiny black specks easily visible in the air pathway.Since it is my understanding that tiny black specs are the problem - i sent that device back too.I included a letter that i would no longer accept a recertified device because they had an obvious quality.Control problem.I made it clear that in the future i would only accept a new device.I have not received a new device nor have i heard anything from philips respironics.Philips respironics has a huge issue with quality control and there apparently is zero oversight regarding the replacement cpap machines that are being sent to their customers.Fda safety report id# (b)(4).

• Brand Name: DREAM STATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 15879062
• MDR Text Key: 304517807
• Report Number: MW5113508
• 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: 11/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALEVE; ASA; LIPITOR ; TOPROL; VITAMIN D
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White