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

Model Number 900MR810

Device Problems Filling Problem (1233); Difficult to Open or Close (2921)

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

Event Type  malfunction  

Event Description

A distributor in (b)(6) reported that the water trap fills up very quickly in the 900mr810 reusable adult breathing circuits and the water traps could not be opened and emptied.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The two complaint 900mr810 breathing circuits are en route to fisher & paykel healthcare in (b)(4) for evaluation.A follow-up report will be provided upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the two complaint 900mr810 breathing circuits were received at fisher & paykel healthcare in (b)(4).The water traps were visually inspected and tested to see if they could be opened.Results: visual inspection revealed that the valve head and valve container had been fitted very tightly on both water traps.Conclusion: the water traps could be opened but only with some difficulty.The water traps are supplied by an external manufacturer.As part of our inwards good quality control procedure samples from each delivery of water traps are checked to ensure that the product meets all specifications and that the valve works freely and seals when the bowl is removed.Our user instructions that accompany the 900mr810 reusable breathing circuit contain the following warnings: clean circuit prior to use and after each patient use, using approved disinfection methods only.Use of unapproved cleaning methods may damage the circuit and reduce it useable life; inspect circuit before re-use, do not use if the circuit shows sign of deterioration, such as cracks, tears or damage; ensure the complete circuit functions correctly with required ventilator settings, before connecting to a patient.

Event Description

A distributor in (b)(6) reported that the water trap fills up very quickly in the 900mr810 reusable adult breathing circuits and the water traps could not be opened and emptied.No patient consequence was reported.

• 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: 4344253
• MDR Text Key: 5174103
• Report Number: 9611451-2014-00947
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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