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

Model Number MR810 HUMIDIFIER

Device Problem Insufficient Heating (1287)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Humidifier did not heat up.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 AND PAYKEL HEALTHCARE
• MDR Report Key: 17509334
• MDR Text Key: 320880908
• Report Number: MW5122939
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2023

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?: No
• Device Model Number: MR810 HUMIDIFIER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2023
• Patient Sequence Number: 1