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

Device Problem Particulates (1451)

Patient Problems Aspiration/Inhalation (1725); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Inhaled black particles of debris from cpap machine, suffered bronchial irritation.Fda safety report id # (b)(4).

• Brand Name: DREAM STATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13177159
• MDR Text Key: 283430145
• Report Number: MW5106488
• 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: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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
• Patient Outcome(s): Disability
• Patient Sex: Male