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

Model Number 900MR810

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint circuit is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that an 900mr810 reusable adult breathing circuit was split at the chamber end of the tubing.This was found before patient use.

Manufacturer Narrative

(b)(4).Method: three complaint 900mr810 reusable adult breathing circuits were returned to fisher & paykel healthcare in (b)(4).The circuits were visually inspected, the bead width, bead height and outside diameter were measured and the film thickness was measured.Results: visual inspection revealed a tear in the film near the chamber end cuffs of all three complaint tubes.The measured bead width, bead height and outside diameter were within specification, as was the measured film thickness.A lot check revealed no other complaints of this nature for lot 130531.Conclusion: we are unable to determine what may have caused the damage noted on the returned 900mr810 breathing circuits.However, it is possible that the limbs may have been pulled at the tube instead of at 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 circuits were 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.- set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported that an 900mr810 reusable adult breathing circuit was split at the chamber end of the tubing.This was found before patient use.

• 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: 5121795
• MDR Text Key: 27675077
• Report Number: 9611451-2015-00425
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: 130531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2013
• 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