MAUDE Adverse Event Report: VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT

Model Number MR290V

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Respiratory Distress (2045); No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device lot number: device 1: 2100917188, device 2: 2100981772, device 3: 2100979484.Three complaint mr290v vented autofeed humidification chambers were received at fisher & paykel healthcare in (b)(4) but device evaluation has not yet begun.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 three mr290 vented autofeed humidification chambers were found broken during use.There was no reported patient consequence.

Manufacturer Narrative

Ps343340.D4 device lot number the lot number was corrected from "see h10" to "191004".Method: three complaint mr290 vented autofeed humidification chambers were returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.The complaint chambers were visually inspected.Results: visual inspection of the returned complaint mr290 chambers revealed a horizontal crack line on the lower part of dome.Conclusion: we are unable to determine what may have caused the crack of the complaint chamber domes.The crack is most likely due to mechanical stress however the stress source is unknown.Every mr290 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 mr290v chambers would have met the required specification at the time of production.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." - "set appropriate ventilator alarms." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

Event Description

A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that three mr290 vented autofeed humidification chambers were found broken during use.It was later reported that the patient showed dyspnoea and increased in respiratory distress.No further consequence was reported.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 10312200
• MDR Text Key: 201101726
• Report Number: 9611451-2020-00649
• 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: 06/23/2020

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: 191004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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 BC160 BUBBLE CPAPF&P MR850 HUMIDIFIER; F&P BC160 BUBBLE CPAPF&P MR850 HUMIDIFIER