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

Model Number 900MR810

Device Problems Air Leak (1008); Leak/Splash (1354)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900mr810 adult heated wall reusable breathing circuit has only recently been returned to fisher & paykel healthcare in (b)(4) and is currently being investigated.We will provide a follow-up report once we have completed our investigation.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) territory manager that a 900mr810 adult heated wall reusable breathing circuit was found leaking after three days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint 900mr810 adult heated wall reusable breathing circuit has only recently been returned to fisher & paykel healthcare in (b)(4) and is currently being investigated.We will provide a follow-up report once we have completed our investigation.Please disregard the earlier report that was sent.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) territory manager that a 900mr810 adult heated wall reusable breathing circuit was found leaking after three days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the actual complaint 900mr810 adult heated wall reusable breathing circuit was not returned to fisher & paykel healthcare (fph) for inspection.A sealed 900mr810 adult heated wall reusable breathing circuit kit, with lot number 130410, was returned to fph instead.The returned 900mr810 reusable breathing circuit was visually inspected and pressure tested for leaks by immersing in a water bath.Results: no physical damage was observed to the returned 900mr810 reusable breathing circuit.No air leak was observed when the tubes were immersed in the water bath.A lot check revealed no other complaints of this nature for lot number 130410.Conclusion: no fault was found to the returned 900mr810 reusable breathing circuit.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The leak reported by the hospital was not replicated during inspection.We are therefore unable to determine what may have caused the reported problem.The user instructions of the 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." "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 to a fisher & paykel healthcare (fph) territory manager that a 900mr810 adult heated wall reusable breathing circuit was found leaking after three days of use.No patient consequence was reported.

• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5645851
• MDR Text Key: 44898121
• Report Number: 9611451-2016-00204
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 130410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2016; 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LVT VENTILATOR
• Patient Outcome(s): Death