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

Model Number DSX500T11

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

I was informed that my cpap machine is deflective and recalled, i did see some black dust like material in the hoses.I contacted my doctor and he said quit using it unless it affects my quality of life, it does.I can't sleep so i need to continue to use it.I was informed yesterday there will not be a solution for 12 months.Fda safety report id# (b)(4).

• Brand Name: PHILIPS CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12844233
• MDR Text Key: 281110152
• Report Number: MW5105472
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MULTI VITAMINS
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White