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

Model Number	MR210
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that a mr210 humidification chamber was leaking water after 2 days of use.The healthcare facility identified a crack in the chamber.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).The subject mr210 humidification chamber has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that a mr210 humidification chamber was leaking water after 2 days of use.The healthcare facility identified a crack in the chamber.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Correction: section d1: brand name updated to fisher & paykel healthcare.Method: the subject mr210 humidification chamber was returned to f&p healthcare in new zealand, where it was visually inspected.Results: visual inspection of the returned device confirmed a horizontal crack near the base flange.Conclusion: the cause of the reported water leak is due to the crack near the base flange.The humidification chamber was most likely exposed to an external mechanical stress.We are unable to confirm the source of the external mechanical stress.Every mr210 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 user instructions that accompany the mr210 humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "do not use the chamber if the seals are not intact when received." "in the event of the chamber leaking, switch the humidifier off and replace the chamber." "ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: HUMIDIFICATION 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19848602
• Report Number: 9611451-2024-00545
• Device Sequence Number: 15053379
• Product Code: BTT
• UDI-Device Identifier: 09420012401489
• UDI-Public: (01)09420012401489(10)2102337488(11)220907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K913368
• 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): 07/04/2024

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: MR210
• Device Catalogue Number: MR210
• Device Lot Number: 2102337488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/28/2024
• Supplement Report FDA Received Date: 09/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown