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 10/08/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the heater wire disconnect alarm sounded on an mr850 humidifier when an rt319 adult breathing circuit was connected.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 complaint rt319 adult breathing circuit was returned to fisher & paykel healthcare (b)(4) for evaluation.The heater wire was resistance tested.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 right heater wire pin inside the overmoulded plug.A lot check revealed no other complaints 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.

• 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: 4221430
• MDR Text Key: 20655540
• Report Number: 9611451-2014-00842
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Date Manufacturer Received: 10/09/2014
• 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: MR850 HUMIDIFIER