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

Model Number RT265

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Data Problem (3196)

Patient Problem No Information (3190)

Event Date 10/30/2015

Event Type  malfunction  

Event Description

After changing the end tidal co2 monitor on the ventilator circuit, the ventilator stopped recording volumes for the patient.Md, rt, and fellow nurses were called to bedside.After troubleshooting, it was found that the hub that connects the circuit to the endotracheal tube was loose and leaking.The entire circuit was changed out for new circuit.

• Brand Name: EVAQUA
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD; 15365 barranca pkwy; irvine, CA 92618
• MDR Report Key: 5340168
• MDR Text Key: 34907867
• Report Number: 5340168
• Device Sequence Number: 1
• Product Code: BZE
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/18/2020
• Device Model Number: RT265
• Device Lot Number: 150218
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1