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

Model Number RT443

Device Problems Circuit Failure (1089); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that an mr850 humidifier displayed the heater wire alarm.During inspection at the fisher & paykel healthcare regional facility in (b)(6) it was found that there was no defect with the mr850, but that the rt443 breathing circuit used in the setup had an open circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt443 adult inspiratory-heated 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 k983112.Method: the complaint rt443 inspiratory heated breathing circuit was returned to fisher & paykel healthcare (b)(4) for inspection.The electrical resistance of the inspiratory heater wire of the breathing circuit was tested using a calibrated multimeter.Results: visual inspection revealed that no damage was observed to the complaint device.Electrical resistance testing showed that the inspiratory limb heater wire resistance was open circuit.Continuity testing showed that the open circuit was located in the connection between the heater wire and the left heater wire pin inside the overmolded plug.A lot check was not performed as no lot number was provided.Conclusion: the cause of the fault is insufficient connection between the heater wire and the heater wire pin.As a result, electrical continuity was not achieved for the full period use of the product.Resistance tests and visual inspection are performed on all breathing circuits during production and those that fail are rejected.This suggests that the heater wire resistance became high post production.

• Brand Name: ADULT INSPIRATORY-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: 3828598
• MDR Text Key: 4390765
• Report Number: 9611451-2014-00465
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT443
• Device Catalogue Number: RT443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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