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

Model Number MR290V

Device Problem Crack (1135)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber cracked during patient use.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to f&p healthcare in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290v chamber confirmed three cracks.Two vertical crack lines were situated to the left and right of the chamber bracket.A third crack originated at water level marking below one of the ports and extended vertically toward the base where it stretches horizontally to the left and right alongside the base.No damage was found to the top of the dome or the chamber base.Conclusion: we are unable to determine the cause of the damage to the humidification chamber.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v 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.Our user instructions that accompany the mr290v 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." - "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 the chamber if the seals are not intact when received, or if it has been dropped.".

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative that a mr290v vented autofeed humidification chamber cracked and leaked water during patient use.There was no patient consequence reported.

• Brand Name: VENTED AUTOFEED 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: 18108086
• MDR Text Key: 328014955
• Report Number: 9611451-2023-01036
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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; F&P MR850 RESPIRATORY HUMIDIFIER; IMI CIRCUIT; IMI CIRCUIT; OA2060 BLENDER; OA2060 BLENDER