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

Model Number 900MR810

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint 900mr810 adult evatherm reusable breathing circuit was returned to fisher & paykel healthcare in (b)(4) for inspection.The returned breathing circuit was visually inspected.Results: visual inspection revealed a tear in the film near the chamber end cuff of the complaint circuit.A lot check revealed no other complaints of this nature for lot 160126.Conclusion: we are unable to determine what may have caused the damage noted on the returned 900mr810 breathing circuit.The customer has confirmed that the subject breathing circuit was in use for a few days before the reported damaged was observed.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 circuit was 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.Clean circuit prior to use and after each patient use, using approved disinfection methods only.Use of unapproved cleaning methods may damage the circuit and reduce it useable life.Set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported that an 900mr810 reusable adult breathing circuit was torn.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 ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5958945
• MDR Text Key: 55000482
• Report Number: 9611451-2016-00574
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2016
• 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: 2100021204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1