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

Device Problem Particulates (1451)

Patient Problems Chest Pain (1776); Cough (4457)

Event Date 07/10/2023

Event Type  Injury  

Event Description

Breathed in small plastic particles from cpap machine resulting in coughing and chest pain, coughed up tiny plastic bits, chest pain continues.No tests yet, waiting for doctor referral.

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS INC.
• MDR Report Key: 17315704
• MDR Text Key: 319045866
• Report Number: MW5119314
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: NP THYROID.; BUPROPION.; FLUOXETINE.; METHYLPHENIDATE.; PROGESTERONE.
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White