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

Model Number DSX500T11W

Device Problems Material Fragmentation (1261); Nonstandard Device (1420)

Patient Problem Cough (4457)

Event Date 07/01/2021

Event Type  Injury  

Event Description

I learned through a boston globe article that the philips cpap dreamstation i've been using for months is part of a recall.The foam is breaking down and i've been breathing the particles every night.No one from philips contacted me.No one from (b)(6).No one from my sleep disorder clinic at (b)(6) medical center.This is unconscionable.I have had an ongoing cough for weeks.Philips claims on their website that few people are affected.They have no clue how many people are affected because there is no place on their website where i can report my symptoms.Who is responsible for notifying patients? who is responsible for offering immediate replacements? fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12166364
• MDR Text Key: 261731081
• Report Number: MW5102527
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11W
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 88