MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR 850 HUMIDIFIER

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

"humidifier not working".Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 17735379
• MDR Text Key: 323471252
• Report Number: MW5145563
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MR 850 HUMIDIFIER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Patient Sequence Number: 1