MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD REUSABLE ADULT BREATHING CIRCUIT; BTT

Model Number 900MR810

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: one 900mr810 reusable adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned circuit was visually inspected and the bead width, bead height, outside diameter and film thickness was measured.Results: visual inspection revealed that the breathing circuit film was torn near the chamber end cuff.Measurement of the bead width, bead height, outside diameter and film thickness revealed that the circuit was within specification.A lot check revealed no other complaints of this nature for lot 141020.Conclusion: based on the investigation conducted, the damage observed to the returned breathing circuit was most likely caused by physical damage in which the circuit limb was pulled at the tube instead of the cuff.All 900mr810 reusable adult breathing circuits are visually inspected and pressure tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damage occurred after the subject breathing circuits were released for distribution.The user instructions that accompany the 900mr801 reusable adult breathing circuits state: "inspect circuit before re-use, do not use if the circuit shows signs of deterioration such as: cracks, tears or damage." "perform a pressure and leak test on the breathing system, and check for occlusions before connecting to a patient." "disconnect tube by handling end connectors only, do not pull or twist tubing as this may cause damage." "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported that the 900mr810 reusable adult breathing circuit was split near the chamber end.This was found after patient use.No patient consequence was reported.

• Brand Name: REUSABLE ADULT BREATHING CIRCUIT
• Type of Device: BTT
• 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: 5171784
• MDR Text Key: 29327545
• Report Number: 9611451-2015-00438
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: 141020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1