MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Corroded (1131); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to retrieve the complaint device for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that two mr290v vented autofeed humidification chambers base plate had a hole.There were no patient consequences.

Event Description

A healthcare facility in montana reported via a fisher & paykel healthcare (f&p) field representative that two mr290v vented autofeed humidification chambers base plate had a hole.The hospital further reported that a nebulised drug with saline solution was administered.There were no patient consequences.

Manufacturer Narrative

Ps(b)(4).Method: the complaint device mr290v humidification chamber was not received at fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is based on the information and photograph provide by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the photograph confirmed a hole was found on the aluminium base of the chamber.It was further reported by the healthcare facility that a nebulised drug with saline solution was administered.Conclusion: based on the information provided by the customer and previous investigations of similar complaints, the cause of the degradation is due the presence of sodium chloride solution in the mr290v chamber.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present 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.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "use usp sterile water for inhalation or equivalent.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• MDR Report Key: 10544514
• MDR Text Key: 208546028
• Report Number: 9611451-2020-00800
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AEROGEN NEBULIZER ADAPTOR; AEROGEN NEBULIZER ADAPTOR