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

Model Number RT380

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult evaqua2 breathing circuit is expected to be returned to fisher & paykel healthcare in (b)(6) for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via our distributor that an rt380 evaqua2 adult breathing circuit was found leaking during the performance test.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in new zealand where it was visually inspected and pressure tested.Results: no damage was found to the breathing circuit or dryline during the visual inspection.The pressure test confirmed that the breathing circuit was within specification and was not leaking.Conclusion: we are unable to determine what caused the leak as reported by the customer as no fault was found with the returned complaint circuit.All rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes.If any faults are detected the whole batch is placed on hold for investigation.The user instructions supplied with the rt380 breathing circuit state: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- set appropriate ventilator alarms.The hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

Event Description

A hospital in south korea reported via our distributor that an rt380 evaqua2 adult breathing circuit was found leaking during the perfomance test.There was no patient involvement.

• Brand Name: ADULT 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: 7665590
• MDR Text Key: 113283554
• Report Number: 9611451-2018-00570
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2100432611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1