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

Device Problems Defective Component (2292); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

This is related to the philips recall.I got a dreamstation 2 as part of the recall.However the unit is defective.The motor is so loud that it keeps me up at night (even with earplugs), and thus is unusable.Philips has refused to assist in any way.I do not have a current medical equipment provider.My previous medial equipment provider just referred me to philips for support.So far, after months, no one is willing to do anything to help.Other have had this some problem in online support groups so i believe this may be a larger problem with philips qa.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14104423
• MDR Text Key: 289275700
• Report Number: MW5108940
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MONTELUKAST
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White