MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number	MR290V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported that the tubing of a rt225 infant bias flow breathing circuit was found broken before patient use.There was no patient involvement.
Event or Problem Description
A healthcare facility in china reported that the water feedset of a mr290v vented autofeed humidification chamber from rt225 infant bias flow breathing circuit was found broken at the connection between water feedset tube and chamber before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrected data: section b5.Describe event or problem: a healthcare facility in china reported that the water feedset of a mr290v vented autofeed humidification chamber from rt225 infant bias flow breathing circuit was found broken at the connection between water feedset tube and chamber before patient use.Section d1.Brand name: vented humidification chamber.Section d2.Common device name: autofeed chamber.Section d2.Product code: btt.Section d4.Model number, catalog number: mr290v.Section g4.Pma/510(k): k934140.Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the healthcare facility, and our knowledge of the product.Result: the healthcare facility reported that the water feedset of a mr290v vented autofeed humidification chamber from rt225 infant bias flow breathing circuit was found broken at the connection between water feedset tube and chamber before patient use.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Common Device Name: AUTOFEED CHAMBER
• 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: 17339746
• Report Number: 9611451-2023-00654
• Device Sequence Number: 14130958
• Product Code: BTT
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2102390155(11)221018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K934140
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023
• 2 Devices were Involved in the Event: 1 2

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 2102390155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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 RT225 INFANT BIAS FLOW BREATHING CIRCUIT
• Patient Age: 7 DA
• Patient Sex: Male