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

Model Number RT319

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the heater wire disconnect alarm sounded from an mr850 during use with an rt319 breathing circuit.This was found before patient use.

Manufacturer Narrative

(b)(4).The product 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 rt319 adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) for investigation.It was visually inspected and a heater wire resistance test was performed.A lot check revealed no other complaints of this nature for the lot number provided.Results: the resistance test revealed that the 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 heater wire pin.Conclusion: conclusion: we are unable to determine what may have caused the observed damage on the heater wire.Electrical open circuits in heater wires can be associated with improper crimping of the heater wire during production, rendering the circuit unable to provide continuity for the full period of use.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 rt319 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.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED 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 ; 9194534000
• MDR Report Key: 3875756
• MDR Text Key: 4564088
• Report Number: 9611451-2014-00523
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2014

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: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 130823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• 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 & PAYKLEY HEALTHCARE MR850