MAUDE Adverse Event Report: VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT

Model Number	MR290V
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not received at fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photography and video provided by the customer revealed a crack line on the baffle of the chamber dome.Conclusion: we are unable to determine what may have caused the crack of the complaint chamber dome.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.Also, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chamber would have met the required specification at the time of production.The user instructions that accompany the mr290v vented autofeed humificiation chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "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." "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure " "do not use beyond 14 days maximum duration of use.".
Event or Problem Description
A distributor in (b)(4) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber base was leaking water during use.There was no reported patient consequence.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Common Device Name: BTT
• MDR Report Key: 10806672
• Report Number: 9611451-2020-00960
• Device Sequence Number: 17166257
• Product Code: BTT
• UDI-Device Identifier: 09420012412430
• UDI-Public: (01)09420012412430(10)2100840724(11)190801
• Combination Product (Y/N): Y
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/10/2020

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 2100840724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2020
• Initial Report FDA Received Date: 11/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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