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

Model Number 900MR810

Device Problem Cut In Material (2454)

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

Event Date 09/25/2014

Event Type  malfunction  

Event Description

A hospital in (b)(4) reported that small cuts on the clear film were found near the cuff of two 900mr810 reusable adult breathing circuits after five to ten uses.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr810 evatherm circuits (1x lot 130700 & 1 x lot 130800) were returned to fisher & paykel healthcare in new zealand and were visually inspected.Results: visual inspection of both devices revealed a 3 mm tear in the film of the heated reusable tube, next to the chamber end over-moulded cuff.A lot check revealed no other complaints of this type for either lot number provided.Conclusion: we were unable to determine what has caused the observed damage.The damage may have been caused by improper cleaning or rough handling of the circuits.The customer had reported that the circuit failed after five to ten uses, which shows the damage occurred after it was released for distribution.The user instructions that accompany the 900mr810 clearly state: -"clean circuit prior to use and after each patient use, using approved disinfection methods only." -"inspect circuit before re-use, do not use if circuit shows signs of deterioration, such as: cracks, tears, or damage." -"disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".

• 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: 4215938
• MDR Text Key: 5037998
• Report Number: 9611451-2014-00834
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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: 130700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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