MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER; BTT

Model Number	MR225X
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative that an mr225x manual fill humidification chamber had cracked at the connection port of the chamber which caused a leak.The chamber was being used for 10 days.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).The complaint mr225x manual fill humidification chamber was returned to fisher & paykel healthcare (f&p) where it was visually inspected.Visual inspection of the chamber revealed it was cracked and broken at the port.We are unable to determine what caused the crack on the chamber dome.It should be noted the complaint mr225 chamber was used for ten days.Every mr225 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.The user instructions that accompany the mr225 humidification chamber specify in the warning section: do not use beyond 7 days maximum duration of use.Do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.Check all connections are tight.

• Brand Name: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13656076
• Report Number: 9611451-2022-00172
• Device Sequence Number: 2455830
• Product Code: BTT
• UDI-Device Identifier: 09420012401519
• UDI-Public: (01)09420012401519(10)2101419729(11)201203
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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: MR225X
• Device Catalogue Number: MR225X
• Device Lot Number: 2101419729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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
• Patient Sex: Unknown