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

Model Number 900MR810

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint 900mr810 reusable adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned breathing circuit was visually inspected, the bead width, bead height, outside diameter, film thickness and heater wire resistance were also measured.Results: visual inspection revealed a tear in the inspiratory limb near the chamber end cuff.The dryline tube was stretched.Black adhesive tape was found on chamber end cuff of the inspiratory limb and one of the cuff's on the dryline.The bead width, bead height, outside diameter, flim thickness and heater wire resistance were all within specification.There was no evidence to suggest that the returned breathing circuit was burnt.A lot check could not be carried out as the lot information was not provided by the customer.Conclusion: based on the inspection carried out the damage observed on the returned breathing circuit was most likely caused by physical damage where the circuit limb was pulled at the tube rather than 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 circuit was released for distribution.The user instructions that accompany the 900mr810 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 healthcare facility in (b)(6), reported to that the tubing of a 900mr810 reusable adult breathing circuits was burnt.Upon inspecting the returned device on (b)(6) 2015 it was found that the tubing 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5322769
• MDR Text Key: 34276220
• Report Number: 9611451-2015-00558
• 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: Respiratory Therapist
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: FPH MR810 HUMIDIFIER