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

Model Number RT380

Device Problems Circuit Failure (1089); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number: 141022, manufacturing date: 10/22/2014, quantity affected: (b)(4).Lot number: 150128, manufacturing date: 01/28/2015, quantity affected: (b)(4).Lot number: not provided, manufacturing date: unknown, quantity affected: (b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuits are not available for investigation.We are currently in the process of obtaining further information from the healthcare facility in order to investigate the reported fault.We will provide a follow up report once we have completed our analysis.

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that 10 rt380 adult dual heated evaqua2 breathing circuits failed the ventilator leak test.This was observed before use on patients.

Manufacturer Narrative

(b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuits are not available for investigation.Attempts to obtain further information with regards to the reported leaks were unsuccessful.Without the complaint devices or additional information from the healthcare facility we would not be able to determine definitively the root cause of the reported fault.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.This suggests that the damage occurred after the subject breathing circuits were released for distribution.The user instructions that accompany the rt380 adult dual heated evaqua2 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 to a fisher & paykel healthcare (fph) field representative that 10 rt380 adult dual heated evaqua2 breathing circuits failed the ventilator leak test.This was observed before use on patients.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5009028
• MDR Text Key: 24674497
• Report Number: 9611451-2015-00356
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• 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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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