MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INSPIRATORY/EXPIRATORY FILTER; BREATHING CIRCUIT BACTERIAL FILTER

Model Number	RT019
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) fisher & paykel healthcare has received the subject device for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that a rt380 adult dual heated evaqua2 breathing circuit failed the pre-use ventilator leak test.It was also reported that the source of the leak was likely to be the rt019 inspiratory/expiratory filter provided as part of the rt380 adult dual heated evaqua2 breathing circuit.There was no patient involvment.
Additional Manufacturer Narrative
(b)(4).Method: the complaint (b)(4).Inspiratory/expiratory filter was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection identified that the filter housing had been misaligned during the manufacturing process.Conclusion: the filter was incorrectly assembled during production.An incorrectly assembled filter would be detected prior patient use, during the pre-use leak testing, as reported in this event.The user instructions supplied with the rt380 breathing circuit state: - visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- set appropriate ventilator alarms.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that a rt380 adult dual heated evaqua2 breathing circuit failed the pre-use ventilator leak test.It was also reported that the source of the leak was likely to be the rt019 inspiratory/expiratory filter provided as part of the rt380 adult dual heated evaqua2 breathing circuit.There was no patient involvment.

• Brand Name: INSPIRATORY/EXPIRATORY FILTER
• Common Device Name: BREATHING CIRCUIT BACTERIAL FILTER
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18984195
• Report Number: 9611451-2024-00243
• Device Sequence Number: 18209101
• Product Code: CAH
• UDI-Device Identifier: 09420012432315
• UDI-Public: (01)09420012432315(10)2102070685(11)220307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: RT019
• Device Catalogue Number: RT019
• Device Lot Number: 2102070685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; SERVO-AIR VENTILATOR; SERVO-AIR VENTILATOR
• Patient Sex: Unknown