MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bronchitis (1752); Cough (4457)

Event Date 12/15/2019

Event Type  Injury  

Event Description

I developed a chronic cough, irritation in my lungs, excess mucus in my throat and eye irritation.I went to multiple doctors, was told it was possibly asthma, or bronchitis, or post nasal drip, no one could give me a solid answer.Fda safety report id # (b)(4).

• Brand Name: HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12481094
• MDR Text Key: 272109725
• Report Number: MW5103988
• Device Sequence Number: 2
• Product Code: BTT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 111