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

Model Number RT114

Device Problem Circuit Failure (1089)

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

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that three rt114 adult inspiratory-heated breathing circuits caused the mr850 humidifier to alarm.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The three complaint rt114 adult inspiratory-heated breathing circuits were not returned to fisher & paykel healthcare in (b)(4) for evaluation.Our evaluation is based on the information provided to us by the hospital and our knowledge of the product.If the complaint devices had been returned, they would have been visually inspected and the resistance of the heater wire would have been measured.Without the devices, we were unable to determine whether there was an actual defect with the rt114 adult inspiratory-heated breathing circuits.A lot check could not be carried out as no lot information was provided.All breathing circuits are tested for connectivity and electrical continuity during production and those that fail are rejected.This suggests that the problem occurred after the product was released for distribution.The user instructions that accompany the rt114 adult inspiratory-heated breathing circuit state the following: - "set appropriate ventilator alarms." (b)(4).

• Brand Name: ADULT 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: 4334642
• MDR Text Key: 15315414
• Report Number: 9611451-2014-00932
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT114
• Device Catalogue Number: RT114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 MR850 HUMIDIFIER