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

Model Number RT380

Device Problems Leak/Splash (1354); Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 circuit has recently been received at fisher & paykel healthcare in (b)(4) for evaluation.We are in the process to determine if fph's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that one rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).This report was sent on its due date (19 may 2017).However the fda gateway was "unavailable" so the report was re-sent on 22 may 2017.Method: the complaint rt380 breathing circuit was returned to fph in (b)(4) for investigation.The complaint device was visually inspected and pressure tested.Result: visual inspection revealed that no damage was found to the breathing circuit or the dryline.Pressure testing revealed that the circuit was within specification.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.The leak the customer experienced was most likely due to the feedset not being connected to the waterbag during the leak test.The feedset winder is designed to secure the feedset and spike during transport and storage.It is not designed to seal the spike.All rt380 adult dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions supplied with the rt380 breathing circuit state: - check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that one rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6488995
• MDR Text Key: 72932843
• Report Number: 9611451-2017-00322
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2100098152(11)161102(17)211102
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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: 2100098152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1