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 Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a distributor that three rt134 adult unheated breathing circuits failed the leak test on a servo-i ventilator.This was found during the setup check and prior to patient use.

Manufacturer Narrative

(b)(4).Method: three rt134 non-heated adult breathing circuits were returned to fisher & paykel healthcare in (b)(4) for evaluation.They were pressure tested and subsequently submerged in a water bath to test for leak.Results: pressure test revealed that all three of the returned circuits exhibited leak and were out of specification.The water bath test showed that the leak on all three of the returned circuits is through the connection between the lid and bowl of the inspiratory and expiratory water traps.Conclusion: the breathing circuit water trap consists of a bowl and lid, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.Our user instructions that accompany the rt134 non-heated adult 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." the hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

• 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: 3982383
• MDR Text Key: 4632100
• Report Number: 9611451-2014-00680
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033710
• 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: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• 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
• Device Lot Number: 130415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2013
• 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