MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of retrieving further information and the complaint rt266 infant breathing circuit.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(4) reported via a (b)(4) representative that the rt266 infant dual heated evaqua2 breathing circuit did not pass the initial leak test before use.There was no patient involvement.

Event Description

A healthcare facility in hong kong reported via a fisher & paykel healthcare (f&p) representative that the rt266 infant dual heated evaqua2 breathing circuit did not pass the initial leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: one complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in new zealand for inspection.The returned device was visually inspected and pressure tested for leaks.Results: visual inspection revealed that there was no damage or defect to the circuit.Pressure test showed that the circuit was within specification and was not leaking.Conclusion: we were unable to determine why the subject circuit failed the ventilator leak testing as there was no fault found with it.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state the following: check all connections are tight before use; perform a pressure and leak test on.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8192166
• MDR Text Key: 131932043
• Report Number: 9611451-2018-01120
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100467801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER; FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER; SERVO-I VENTILATOR; SERVO-I VENTILATOR