MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported that swivel wye of an rt380 breathing circuit is disconnecting easily.No patient consequence reported.

Manufacturer Narrative

(b)(4).The complaint rt380 evaqua2 breathing circuit is en route to fisher & paykel healthcare (b)(4) for evaluation.A follow up report will be provided upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 evaqua2 breathing circuit was returned to fisher & paykel healthcare (b)(4) for evaluation.The device was visually inspected and pressure tested.Result: the visual inspection did not reveal any damage to the breathing circuit of the dryline.The pressure test was performed and the product was within specification.No fault was found with the device.Conclusion: we were unable to determine the cause of the reported incident as no fault was found with the device.All rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The user instructions supplied with the rt380 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.The hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

Event Description

A hospital in the (b)(6) reported that swivel wye of an rt380 breathing circuit is disconnecting easily.No patient consequence reported.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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: 4672137
• MDR Text Key: 5619869
• Report Number: 9611451-2015-00195
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 140923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• 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