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

Model Number RT204

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the heated breathing circuit disconnect alarm sounded when the mr850 was in use with an rt204 adult breathing circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt204 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is (b)(4).Method: the complaint rt204 adult breathing circuit inspiratory limb of the breathing circuit was returned to fisher & paykel healthcare in new zealand and the electrical resistance of the heater wire was tested using a multimeter.A continuity test was used to locate the break in the heater wire.Results: electrical resistance testing showed that the inspiratory limb heater wire was open circuit.The inspiratory heater wire was open circuit due to a break in the connection between the heater wire and heater wire pin inside the overmoulded plug.A lot check revealed no other complaints of this nature for this lot number.Conclusion: electrical open circuits in heater wires can be associated with improper crimping of the heater wire during production, such that is unable to provide continuity for the full period of use.All breathing circuits are electrically tested during production and those that fail are rejected.This suggests that the complaint device was within specification prior to being released for distribution.

• Brand Name: ADULT DUAL-HEATED 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: 3800786
• MDR Text Key: 17611235
• Report Number: 9611451-2014-00403
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 04/07/2014

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: RT204
• Device Catalogue Number: RT204
• Device Lot Number: 130912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2013
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER