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

Model Number RT236

Device Problem Air Leak (1008)

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 field representative that there was an air leak on the expiratory limb of an rt236 infant dual heated evaqua breathing circuit.The leak was discovered by a nurse as they were turning the patient.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint expiratory limb of the rt236 infant breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The breathing circuit was visually inspected, pressure tested and subsequently submerged in a water bath to test for leak.Results: visual inspection revealed a hole on the evaqua expiratory limb approximately 2mm x 6mm.The pressure test identified that the returned circuit exhibited leak and was out of specification.The water bath test showed the source of the leak to be the hole on the expiratory limb.A lot check could not be performed as the lot date was not provided.Conclusion: the damage observed on the returned evaqua expiratory limb indicates that it was punctured by a blunt object.All rt236 breathing circuits are pressure tested for leak prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.This suggests that the affected breathing circuit was damaged after it was released for distribution.(b)(4).The user instructions that accompany the rt236 infant breathing circuit state the following: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "use caution when positioning the circuit.Sharp or harsh edges and surfaces may damage the expiratory limb." "set appropriate ventilator alarms.".

• 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: 3620902
• MDR Text Key: 20011374
• Report Number: 9611451-2014-00112
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

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: RT236
• Device Catalogue Number: RT236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/10/2014
• 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