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

Model Number RT100

Device Problem Disconnection (1171)

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

Event Date 07/10/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that the rt100 adult dual heated breathing circuit caused the heater wire disconnect alarm on an mr850 respiratory humidifier.This was found after five hours of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt100 breathing circuit is not sold in the usa but is similar to a product which sold in the usa.The 510(k) number for that product is k983112.Method: the complaint rt100 adult dual heated breathing circuit was returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.The returned circuit was visually inspected and the inspiratory and expiratory heater wires were resistance tested using a calibrated multimeter.Additionally, continuity testing was also conducted to check the electrical connection between the heater wires and the heater wire pins.A lot check revealed no other complaints of this nature for lot 131208.Results: visual inspection revealed no physical damage to the returned circuit.The resistance test revealed that the inspiratory heater wire was open circuit.No fault was found with the expiratory heater wire.Continuity testing showed that the open circuit was located in the connection between the heater wire and the right heater wire pin inside the overmoulded plug.Conclusion: electrical open circuits in heater wires can be associated with insufficient connection of the heater wire pin during production, such that it is unable to provide continuity for the full period of use.All rt100 breathing circuits are electrical resistance and continuity tested during production, and those that fail are rejected.This suggests that the subject inspiratory heater wire became open circuit after released for distribution, possibly as a result of insufficient connection.(b)(4).

• 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: 4021667
• MDR Text Key: 19719098
• Report Number: 9611451-2014-00715
• 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: 07/30/2014

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: RT100
• Device Catalogue Number: RT100
• Device Lot Number: 1312080301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2013
• 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: FPH MR850 RESPIRATORY VENTILATOR