MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT340

Device Problems Improper Device Output (2953); Temperature Problem (3022)

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

Event Date 09/09/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the temperature of an rt340 adult breathing circuit did not increase when connected to an mr850 humidifier.This was observed after five days of use.No patient consequence was reported.

Manufacturer Narrative

Method: the complaint rt340 adult breathing circuit was returned to fisher & paykel healthcare (b)(6) for evaluation.The electrical resistance of the heater wires of the inspiratory and expiratory limbs was tested using a multimeter.Results: electrical resistance testing showed that the expiratory limb was within specification but that the inspiratory limb heater wire resistance was out of specification.Continuity testing and visual inspection revealed that the high resistance in the inspiratory limb heater wire was due to a poor connection between the heater wire and the connector pins.A lot check revealed that no other similar complaints have been received for lot date 140310.Conclusion: the resistance of the inspiratory limb heater wire was out of specification.This was most likely due to a poor connection between the heater wire and the connector pins that only developed after it was released for distribution.All rt340 breathing circuits are subjected to a continuity test on the production line which is followed by a resistance test and a visual inspection.Any circuits that fail are rejected.The customer has confirmed that the subject breathing circuit was in use for five days before the problem was observed, which indicates that the inspiratory limb heater wire only became out of specification after it was released for distribution.

• Brand Name: ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
• Type of Device: BZE
• 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: 4157771
• MDR Text Key: 4767572
• Report Number: 9611451-2014-00808
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983112
• 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: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT340
• Device Catalogue Number: RT340
• Device Lot Number: 140310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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 MR850 HUMIDIFIER