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

Model Number 900MR810

Device Problems Hole In Material (1293); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6), reported that a (b)(4) reusable adult breathing circuit was melted and created a hole in the tube.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) reusable adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned circuit was visually inspected and the resistance of the heater wire was measured using a calibrated multimeter.Results: visual inspection revealed that the tube was melted approximately 41 cm from the distal connector.No damage was noted to the heater wire.Resistance test of the heater wire showed that it was within specification.A lot check revealed no other complaints of this nature for lot 141223.Conclusion: based on the inspection conducted the damage observed on the returned breathing circuit was most likely caused by an external heat source.The only source of heat in the breathing circuit is the heater wire which was not damaged.All (b)(4) 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 (b)(4) reusable adult breathing circuit 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.".

• 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: 4659293
• MDR Text Key: 5680115
• Report Number: 9611451-2015-00187
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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: 141223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2014
• 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
• Treatment: (B)(4) RESPIRATORY HUMIDIFIER