MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT; BTT

Model Number RT319

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel field representative that the heaterwire of an rt319 adult bi-level/cpap inspiratory-heated breathing circuit caused a fisher & paykel healthcare mr850 respiratory humidifier to sound a disconnect alarm.This occurred prior to patient use.

Manufacturer Narrative

The rt319 adult bi-level/cpap inspiratory-heated breathing circuit that is referred to in the event description 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 k983112.Method: the complaint rt319 breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.A heaterwire resistance test was carried out using a calibrated multimeter.Results: the resistance test revealed that the inspiratory heater wire was out of specification.Continuity testing and visual inspection revealed that the open circuit in the inspiratory heater wire was located between the heater wire and the right heater wire pin inside the overmoulded plug.A lot check revealed one other complaint of this type for the lot number provided.Conclusion: we are unable to determine what may have caused the observed damage on the heater wire.Resistance tests and visual inspections are performed on all breathing circuits during production and circuits that fail are rejected.This suggests that the heater wire became open circuit after the product was released for distribution.The user instructions that accompany the breathing circuit state the following: - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms." hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

• Brand Name: ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 4271905
• MDR Text Key: 5029824
• Report Number: 9611451-2014-00880
• 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: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 140611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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