MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber base plate had holes and water was leaking through the holes during use.There was no reported patient consequence.

Event Description

A healthcare facility in florida reported via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber base plate had holes and water was leaking through the holes during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection confirmed that holes were found on the base of the chamber.Further analysis of the subject mr290v vented autofeed humification chamber confirmed the presence sodium chloride.Conclusion: the degradation of the aluminium baseplate is most likely due to the presence of sodium chloride solution in the mr290v vented autofeed humidification 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: 12055749
• MDR Text Key: 260965709
• Report Number: 9611451-2021-00725
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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