MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE INC. MR850; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR850

Device Problems Overheating of Device (1437); Smoking (1585); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2016

Event Type  malfunction  

Event Description

Ventilator heater began to smoke when switched to invasive setting.A circuit board inside of the humidification device overheated.Manufacturer response for mr850, humidifier, heated (per site reporter): faulty mr850 pcb.It was replaced and the equipment was returned to us approximately 11 days after the event.

• Brand Name: MR850
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE INC.; 15365 barranca pkwy; irvine, CA 92618
• MDR Report Key: 5623642
• MDR Text Key: 44143236
• Report Number: 5623642
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MR850
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR