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

Model Number RT280

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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 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
• Type of Device: BZE
• MDR Report Key: 10281051
• MDR Text Key: 200041923
• Report Number: 9611451-2020-00624
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012430373
• UDI-Public: (01)09420012430373(10)2100887974(11)190926
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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