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

Model Number MR290

Device Problem Filling Problem (1233)

Patient Problem No Information (3190)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Hfov alarmed.Fisher & paykel mr290 which was attached to airlife sterile water for inhalation was not filled up with the water.Even under the pressure, the device will not fill with water.

• Type of Device: HUMIDIFIER, RESPIRATORY GAS,(DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr; irvine CA 92618
• MDR Report Key: 6983069
• MDR Text Key: 90456923
• Report Number: 6983069
• 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: Patient
• Type of Report: Initial
• Report Date: 10/16/2017,10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MR290
• Device Catalogue Number: MR290
• Other Device ID Number: 0839 L4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2017
• 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: AIRLIFE STERILE WATER FOR INHALATION WITH TUBING