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

Model Number RT340

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2013

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that an rt340 adult breathing circuit failed the leak test on a servo-i ventilator.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint device was received at fisher & paykel healthcare (fph) (b)(4) and was visually inspected.The device was pressure tested and submerged in a water bath to check for leaks.Results: a visual inspection showed there was not enough glue in the patient end connector.The pressure test revealed the device was not performing within specification.The water bath test showed the leak was occuring at the proximal connector.Conclusion: all breathing circuits are visually inspected and pressure tested before releasing for distribution, and those that fail are rejected.The observed leak was caused by insufficient glue being injected into proximal connector such that it did not form a permanent seal during the assembly process.A lot check revealed one other complaints of this nature for the lot number provided.All rt340 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution and any circuit that fails is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes; if this test detects a fault, the whole batch is placed on hold for further investigation.The user instructions supplied with the rt340 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.

• Brand Name: ADULT 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3588442
• MDR Text Key: 4136958
• Report Number: 9611451-2014-00069
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2013

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: RT340
• Device Catalogue Number: RT340
• Device Lot Number: 130722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2014
• Initial Date Manufacturer Received: 12/24/2013
• Initial Date FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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
• Treatment: SERVO-I VENTILATOR