MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected.Results: visual inspection of the expiratory limb revealed holes in the limb.The biggest hole was found approximately 22 cm away from the patient end connector and it had rough edges.The smaller holes were found close to the biggest hole and these holes had sharp edges.A lot check was not performed as a lot number was not provided.Conclusion: the sustained damage to the evaqua expiratory limb indicates that the circuit was most likely punctured with a sharp object.All breathing circuits are pressure tested for leaks prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.The subject rt265 infant breathing circuits would have met the required specification at the time of production.The customer noted that the affected breathing circuit was used for 7 days, which suggests that the affected circuit was damaged after it was released for distribution.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: "perform a pressure and leak test on the breathing system and check for occlusion before connecting to a patient." "set appropriate ventilator alarms." "check all connections are tight before use.".

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the expiratory limb of an rt265 infant dual-heated evaqua2 breathing circuit was found damaged.No patient consequence was reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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 ; 9494534000
• MDR Report Key: 5530812
• MDR Text Key: 41308490
• Report Number: 9611451-2016-00116
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Date Manufacturer Received: 03/01/2016
• 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