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

Model Number DSX700H11C

Device Problems Fitting Problem (2183); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2019

Event Type  malfunction  

Event Description

Philips respironics dreamstation bipap machine is malfunctioning owing to a design defect.The water chamber cover does not properly fit tight enough to prevent seepage of air thereby causing the blower and controller to malfunction and operate in a manner whereby the inhalation and exhalation prescribed settings cannot be delivered to the pt.I contacted philips to report the problem as my dme provider has observed that pts have been reporting issues with the fit of the cover over the water chamber.Philips refused to assist and cited to the 2 year warranty period and simply said to buy another machine and pay the co-pay.I explained that they should understand that this defect causes erroneous pressures to be administered to the pt which is not in compliance with the prescribed settings.I brought my device to my dme supplier for testing and the problem was easily detected at their facility.Dme provider was able to observe the problem with my device.Additionally, a brand new machine was unpacked and tested in my presence and had the same problem with the cover over the chamber "heaving" and not providing an airtight fit.Dme provider advised that there is a clear quality and performance issue impacting device usage.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 8879336
• MDR Text Key: 154919117
• Report Number: MW5088918
• 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: 07/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 123