MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. MR850 RESPIRATORY HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS

Model Number MR850

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Smoking (1585)

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

Event Date 05/29/2017

Event Type  malfunction  

Event Description

It appears that during a treatment, a component on a circuit board of the humidifier during ventilation overheated and at least smoldered or possibly ignited as there is smoke staining noted when bio med looked inside the unit.The treatment was stopped when the smoldered smell started.

• Brand Name: MR850 RESPIRATORY HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr.; irvine CA 92618
• MDR Report Key: 6666571
• MDR Text Key: 78381041
• Report Number: 6666571
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.