MAUDE Adverse Event Report: FISHER PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number RT266

Device Problems Degraded (1153); Material Discolored (1170)

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

Event Date 11/16/2018

Event Type  malfunction  

Event Description

Humidifier chamber on the ventilator was brown inside and crusted around the edges.

• Brand Name: FISHER PAYKEL HEALTHCARE
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): FISHER PAYKEL HEALTHCARE LIMITED; 173 technology dr; irvine CA 92618
• MDR Report Key: 8435928
• MDR Text Key: 139370833
• Report Number: 8435928
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2019,11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100524920
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1