MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT235

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that an rt235 infant dual-heated evaqua breathing circuit generated a whistling noise.The hospital reported that the noise was due to a leak caused by a crack in the patient end connector.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint rt235 infant dual-heated evaqua breathing circuit was not returned to fisher & paykel healthcare in (b)(6) for evaluation.The complaint device was lost in transit between the hospital and fisher & paykel healthcare regional office in (b)(6).Therefore, our investigation is based on the information provided by the hospital and our knowledge of the product.The hospital reported that a nurse heard a whistling sound at the connection area of the patient end.Upon further inspection a slight crack was found on the connector.The hospital was unable to confirm how long the rt235 breathing circuit had been in use.Without the return of the complaint device we are unable to determine what may have caused the problem experienced by the customer.All rt235 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution and any circuit that fails is discarded.This suggests that the subject breathing circuit was damaged after it was released for distribution.The user instructions that accompany the rt235 infant dual-heated evaqua 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." - "this product is intended to be used for a maximum of 7 days." device not returned to manufacturer.

• Brand Name: INFANT DUAL-HEATED EVAQUA 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, CA 92618-2216
• MDR Report Key: 3633003
• MDR Text Key: 3985072
• Report Number: 9611451-2014-00136
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K034026
• 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: 01/20/2014

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: RT235
• Device Catalogue Number: RT235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/18/2014
• 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