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

Model Number MR290HFV

Device Problem Crack (1135)

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

Event Date 12/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290hfv 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 canada reported, via a fisher & paykel healthcare (f&p) field representative, that a mr290hfv vented autofeed humidification chamber was found cracked during patient use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the mr290hfv 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 mr290hfv vented autofeed humidification chamber confirmed a vertical crack in the chamber dome.Conclusion: we are unable to determine the cause.The mr290hfv chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290hfv 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 mr290hfv 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 healthcare facility in canada reported, via a fisher & paykel healthcare (f&p) field representative, that a mr290hfv vented autofeed humidification chamber was being used with a ventilator in niv cpap mode.After approximately half an hour of patient use the ventilator was alarming for a leakage.On investigation by the clinician subject it was identified that there was a crack in the mr290hfv vented autofeed humidification chamber.There was no reported patient consequence.

• 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: 18279966
• MDR Text Key: 329906974
• Report Number: 9611451-2023-01138
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290HFV
• Device Catalogue Number: MR290HFV
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• 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.; F&P RT110 ADULT ANAESTHESIA CIRCUIT.; F&P RT110 ADULT ANAESTHESIA CIRCUIT.; PURITAN BENNETT¿ 980 VENTILATOR.; PURITAN BENNETT¿ 980 VENTILATOR.