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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT
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VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT Back to Search Results
Model Number MR290V
Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2020
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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber was leaking during use.There was no reported patient consequence.
 
Event Description
A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that a mr290 vented autofeed humidification chamber was cracked and leaking during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the mr290v vented autofeed humidification chamber was discarded by the customer and was not available for evaluation.Our investigation is based on the event description reported by the customer and our knowledge of the product.Results: the customer reported that the mr290v chamber dome cracked.Conclusion: without the complaint device, we are unable to confirm the reported event.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.The subject mr290v chamber 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." "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" "ensure there is water supply connected to the chamber and that water is present within the chamber" our user instructions that accompany the mr850 respiratory humidifier state the following: "ensure appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use.".
 
Manufacturer Narrative
(b)(4).We have received the complaint mr290v vented autofeed humidification chamber at fisher & paykel healthcare (f&p) for evaluation.We are currently in process of our investigation and will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that a mr290 vented autofeed humidification chamber was leaking during use.There was no reported patient consequence.
 
Event Description
A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that a mr290 vented autofeed humidification chamber was leaking during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290 vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed results: visual inspection of the returned mr290 chamber revealed multiple crack lines on the lower part of the dome.In addition, ink smudges were observed on the dome indicating that the complaint chamber was likely exposed to an ethanol-based solution.Conclusion: we are unable to determine the root cause of the chamber crack, however our investigation indicates that the crack is most likely due to mechanical stress.The stress source was unable to be identified.It should be noted that based on previous investigations of the mr290v chamber, exposure to ethanol-based hand sanitizer may affect the integrity of the chamber dome and can result in cracking.The mr290 chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.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 chamber 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." "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" "ensure there is water supply connected to the chamber and that water is present within the chamber" "do not use the chamber if the seals are not intact when received, or if it has been dropped." our user instructions that accompany the mr850 respiratory humidifier state the following: "ensure appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use.".
 
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Brand Name
VENTED AUTOFEED HUMIDIFICATION CHAMBER
Type of Device
BTT
MDR Report Key10653844
MDR Text Key212137658
Report Number9611451-2020-00863
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMR290V
Device Catalogue NumberMR290V
Device Lot Number1312 L3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; FABIAN VENTILATOR; FABIAN VENTILATOR; FABIAN VENTILATOR; FABIAN VENTILATOR; MEDIN TUBE SYSTEM; MEDIN TUBE SYSTEM; MEDIN TUBE SYSTEM; MEDIN TUBE SYSTEM
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