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

Model Number 900MR810

Device Problems Device Issue (2379); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to obtain the complaint 900mr810 adult heated wall reusable breathing circuits for evaluation, to determine if they had a malfunction which might have caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that two 900mr810 adult heated wall reusable breathing circuits developed blisters on the tube.The patient's family was advised by their respiratory therapist not to place to the tubing under a blanket.No patient consequence was reported as a result of this incident.

Manufacturer Narrative

Report source correction: unticked 'foreign' as report source.(b)(4).Method: one complaint 900mr810 adult heated wall reusable breathing circuit was received at fph in (b)(4) for evaluation.It was visually inspected and electrical resistance tested.Results: visual inspection revealed that the tubing film was stretched and damaged approximately midway between the breathing circuit cuffs.No melting of the tube or heaterwire was observed.The electrical resistance of the heaterwire was within specification.Conclusion: based on our investigation, the observed damage most likely occurred from the tube being stretched.All 900mr810 adult heated wall reusable 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 adult heated wall reusable breathing circuit state the following: - "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." - "do not cover the circuit with materials such as blankets, towels or bed linen." - "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that two 900mr810 adult heated wall reusable breathing circuits developed blisters on the tube.The patient's family was advised by their respiratory therapist not to place to the tubing under a blanket.No patient consequence was reported as a result of this incident.

• Brand Name: ADULT HEATED WALL REUSABLE 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: jon stevens ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6408565
• MDR Text Key: 70092661
• Report Number: 9611451-2017-00211
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• 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: NP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MR810 RESPIRATORY HUMIDIFIER