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

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2019

Event Type  Injury  

Event Description

The cpap was giving me a rash and runny nose and watery eyes.The said machine was recalled by philips.Foam inside of the machines was toxic.I went to see the respiratory therapist at (b)(6) cpap and he said to stop using the soclean machine, because the ozone that it uses could cause those symptoms.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12868860
• MDR Text Key: 281279869
• Report Number: MW5105548
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 11/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 86; COQ10; PLAVIX 75; QUINAPRIL HCL 20/25; TUMERIC ; USING CPAP MACHINE SINCE 2003
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White