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

Model Number DSX500T11

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem Headache (1880)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

(b)(6) 2019 my philips dreammaker auto cpap developed some black mold on the gaskets for the humidifier water tray.I replaced the gaskets and ran ozone through the device to disinfect it using a cpap hose ozone generator i had.I received the philips recall letter this month and noticed that the exhaust port of my cpap is covered with white dust or particles so have stopped using it.The brighter black streak is where i wiped some of the white dust off with a q-tip.My concern is that i had headaches in the morning for the past few months and wonder if this dust is from the noise silencing foam and if it was the cause.You may have the device to disassemble and analyze as i will no longer be using it (i have a second device).All i ask is that you confirm what the dust is.It's date of manufacture was oct 27, 2015.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMMAKER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12239027
• MDR Text Key: 264274540
• Report Number: MW5102805
• 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: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/27/2015
• Device Model Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 88