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

Model Number RT235

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the swivel of a rt235 infant dual-heated evaqua breathing circuit was found damaged before use.

Manufacturer Narrative

(b)(4).Method: the complaint rt235 infant dual-heated evaqua breathing circuit was received at fisher & paykel healthcare in (b)(4) for evaluation.The breathing circuit was visually inspected and pressure tested to check for leakage.Results: visual inspection revealed a crack on the swivel wye.The pressure test revealed that the complaint breathing circuit was within specification and did not exhibit significant leak.A lot check revealed no other similar complaints for lot date 131031.Conclusion: we are unable to determine what has caused the cracking but the damage appeared to be the result of physical impact.All rt235 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The user instructions that accompany the rt235 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." - "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: 4343465
• MDR Text Key: 19802957
• Report Number: 9611451-2014-00942
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/01/2014

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
• Device Lot Number: 131031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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