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

Model Number MR290EU

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

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

Event Date 06/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint (b)(4) 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 investigation.

Event Description

A healthcare facility in italy reported via a fisher & paykel healthcare (f&p) field representative, that the base of a (b)(4) vented autofeed humidification chamber was found with "hole in the middle due to corrosion".There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4).Vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photographs provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photographs revealed a hole in base of chamber and deposits can be seen on the aluminum base and heater plate.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, the cause of the chamber base damaged was most likely due to contamination induced corrosion.The (b)(4).Chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every (b)(4).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.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 subject (b)(4).Chamber would have met the required specification at the time of production.Our user instructions that accompany the (b)(4).Vented autofeed humidification chamber state 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 for humidification.Do not add other substances to the water.".

Event Description

A healthcare facility in italy reported via a fisher & paykel healthcare (f&p) field representative, that the base of a mr290eu vented autofeed humidification chamber was found with "hole in the middle due to corrosion".There was no patient consequence.

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17167893
• MDR Text Key: 317903842
• Report Number: 9611451-2023-00553
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290EU
• Device Catalogue Number: MR290EU
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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: F&P MR850 RESPIRATORY HUMIDIFIER.