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

Model Number RT236

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint breathing circuits caused or contributed to the reported event.We are also attempting to obtain the subject complaint devices for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A healthcare facility in (b)(6) reported via an fisher & paykel healthcare field representative that an rt236 infant dual heated evaqua breathing circuit "broke apart and the filter fell off".This was found before use on a patient.

Manufacturer Narrative

(b)(4).Method: the swivel from the complaint rt236 infant dual-heated evaqua breathing circuit, parts of the inspiratory and expiratory circuit and an fph rt019 respiratory filter were returned to fisher and paykel healthcare in (b)(4) for evaluation.The returned complaint devices were visually inspected.A pressure test to check for leakage could not be performed with the returned circuits, as the customer had cut the inspiratory and expiratory limbs.Results: visual inspection revealed no damage to the components (swivel elbow and swivel wye) and the returned rt019 filter.The swivel was returned disassembled and once reassembled it formed a tight fit.A lot check revealed no other complaints for lot 130321.Conclusion: we are unable to determine what may have caused the problem reported by the customer.All rt236 infant dual-heated evaqua breathing circuits, including the swivel assemblies, are visually inspected and pressure and flow tested during production.Those that fail are rejected.The hospital staff confirmed that the subject breathing circuit was in use before the event occurred, which indicates that the circuit became damaged after it was released for distribution.Our user instructions that accompany the rt236 infant dual-heated evaqua breathing circuit state the following: 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 healthcare facility in (b)(6) reported via an fisher and paykel healthcare field representative that an rt236 infant dual heated evaqua breathing circuit "broke apart and the filter fell off." further information was received from the customer on 30 nov 2016 that the reported event occured during use.No patient consequence was reported.

• Brand Name: INFANT DUAL-HEATED EVAQUA 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6046196
• MDR Text Key: 58298922
• Report Number: 9611451-2016-00691
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K034026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT236
• Device Catalogue Number: RT236
• Device Lot Number: 130321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• 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