MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NON-HEATED ADULT BREATHING CIRCUIT; BZO

Model Number RT134

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that an rt134 adult breathing circuit failed the leak test on a servo-i ventilator.This was found before use on a patient.

Manufacturer Narrative

(b)(4).Method: the complaint rt134 breathing circuit was visually inspected, pressure tested and immersed in a water bath to test for leaks.Results: pressure testing revealed that the circuit was out of specification.The water bath test revealed a leak between the water trap bowl and the lid.A lot check was unable to be performed as no lot number was provided by the hospital.Conclusion: the water trap of the breathing circuit consists of two parts, a lid and a bowl which can be disconnected during use for draining condensate.The water trap leak was located at the seal between the water trap bowl and the water trap lid.All circuits are pressure tested for leaks during production and those that fail are rejected.This suggests any leak must have developed post production during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The customer had commented that the complaint circuits passed the ventilator leak test which suggests that the water traps became loose during setup of the devices.The user instructions that accompany the rt134 adult breathing circuit state the following: - 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: NON-HEATED ADULT BREATHING CIRCUIT
• Type of Device: BZO
• 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 ; 9194534000
• MDR Report Key: 3898466
• MDR Text Key: 20296530
• Report Number: 9611451-2014-00555
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT134
• Device Catalogue Number: RT134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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