MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT UNHEATED BREATHING CIRCUIT; BZO

Model Number RT134

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

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that an rt134 adult unheated breathing circuit failed the ventilator leak test.This was observed before use on a patient.

Manufacturer Narrative

(b)(4).Method: the complaint rt134 adult unheated breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The breathing circuit visually inspected, pressure tested, and immersed in a water bath to test for leaks.Results: the pressure test result for the complaint breathing circuit was out of specification due to an excessive leak.When the breathing circuit was immersed in the water bath, the leak was observed at the connection between the lid and the bowl of the water trap.A lot check could not be performed as no lot information was provided.Conclusion: the breathing circuit water trap consists of a bowl and a 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 any leak must have developed after the rt134 adult unheated 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 adult unheated 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 alarms." hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

• Brand Name: ADULT UNHEATED BREATHING CIRCUIT
• Type of Device: BZO
• 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, CA 92618-2216
• MDR Report Key: 3903226
• MDR Text Key: 4648272
• Report Number: 9611451-2014-00578
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• 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: 06/24/2014
• Date Manufacturer Received: 06/06/2014
• 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: PB840 VENTILATOR