MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937)

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

Event Date 04/26/2021

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 distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber failed the ventilator leak test prior to patient use.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that two mr290v vented autofeed humidification chambers failed the ventilator leak test prior to patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Section b5 was corrected to change quantity of complaint mr290 units.Method: one of the two complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was pressure tested.Results:the pressure test revealed a leak at the water feedset tube and chamber dome connection on the chamber.Conclusion: we are unable to determine the cause of the reported event.However, it was likely due to the water feedset tube being pulled away from the chamber dome.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.Also, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chambers would have met the required specification at the time of production.The user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "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.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• MDR Report Key: 11881514
• MDR Text Key: 255596880
• Report Number: 9611451-2021-00607
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: 200209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2020
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER.; F&P MR850 RESPIRATORY HUMIDIFIER.; F&P RT380 ADULT BREATHING CIRCUIT.; F&P RT380 ADULT BREATHING CIRCUIT.; PURITAN BENNETT¿ 840 VENTILATOR.; PURITAN BENNETT¿ 840 VENTILATOR.