MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number	RT280
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt280 adult evaqua2 breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that two rt280 adult dual-heated evaqua2 breathing circuit were found with a slit causing the ventilators to alarm.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Method: two complaint rt280 adult evaqua2 breathing circuits were recevied at fisher & paykel healthcare (f&p) new zealand where it was visually inspected.Results: visual inspection revealed that the expiratory limb of device 1 and inspiratory limb of device 2 were both cut.It was further observed that matching cuts were found on the top of the returned packaging bags respectively.Conclusion: the damages appeared to have been made with a sharp object, such as a knife or boxcutter.All rt280 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.This suggests that the subject breathing circuits were damaged after they were released for distribution.The user instructions supplied with the rt280 breathing circuit state: - perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged.
Event or Problem Description
A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative, that two rt280 adult dual-heated evaqua2 breathing circuit were found with a slit causing the ventilators to alarm.There were no patient consequences.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Common Device Name: BZE
• MDR Report Key: 10281051
• Report Number: 9611451-2020-00624
• Device Sequence Number: 2912489
• Product Code: BZE
• UDI-Device Identifier: 09420012430373
• UDI-Public: (01)09420012430373(10)2100887974(11)190926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RT280
• Device Catalogue Number: RT280
• Device Lot Number: 2100887974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/06/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1