MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. EVAQUA; HEATER, BREATHING SYSTEM

Model Number RT235

Device Problems Hole In Material (1293); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Upon set-up, these circuits were set-up and found to be normal.Once treatment was started, one circuit was found to have a tear and the second circuit was found to have a hole that could look like a puncture or melted point.Both defects are on the exhalation side of the line.

• Brand Name: EVAQUA
• Type of Device: HEATER, BREATHING SYSTEM
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.; 15365 barranca parkway; irvine CA 92618
• MDR Report Key: 4071516
• MDR Text Key: 4827550
• Report Number: 4071516
• Device Sequence Number: 1
• Product Code: BZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: RT235
• Device Catalogue Number: RT235
• Device Lot Number: 140522
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2014
• Patient Sequence Number: 1