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

Model Number DSX500T11

Device Problem Nonstandard Device (1420)

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Began using philips dreamstation recalled cpap in 2018.Diagnosed with colon cancer and nodules on lungs.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17228277
• MDR Text Key: 318289481
• Report Number: MW5118957
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500T11
• Patient Sequence Number: 1
• Treatment: AND HERBAL REMEDIES BEING USED.; HIGH BLOOD PRESSURE MEDICATION. ; NON-PHILIPS CPAP MACHINE.
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White