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

Model Number 900MR810

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

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.The bead width, bead height, outer diameter and film thickness were also measured.Results: visual inspection revealed that the breathing circuit film was torn near the patient end cuff.The bead width, bead height, outer diameter and film thickness were all within specifications.The dry line tube was found to have been stretched.A lot check revealed no other complaints of this nature for lot number 150106.Conclusion: based on the investigation conducted, the damage observed to the returned breathing circuit was most likely caused by physical damage.It appears that the subject breathing circuit was pulled at the tube part instead of the cuff, causing the fault reported by the healthcare facility.All 900mr810 adult evatherm 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 900mr801 adult evatherm reusable 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.".

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the tube of a 900mr810 adult evatherm reusable breathing circuit was split.This was observed after a month of use.No patient consequence was reported.

• Brand Name: ADULT EVATHERM REUSABLE BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5272143
• MDR Text Key: 32867557
• Report Number: 9611451-2015-00520
• 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
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• 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: 150106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1