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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER
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VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290V
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint mr290v vented autofeed humidification chamber is currently en-route to fisher & paykel healthcare 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 base plate had a pin-hole and water was leaking through the pin-hole.The hospital further reported that nebulised drug diluted in saline solution was administered, and patient secretion and condensation in the breathing circuit was returned to the mr290v vented autofeed humidification chamber.It was also reported that the mr290v chamber was used for approximately 12 days.There were no patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the complaint device mr290v humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection confirmed that a hole was found on the base of the chamber.Additionally, a stain was found on the inside of the chamber dome and base.Further analysis of the subject mr290v chamber base confirmed the presence sodium chloride in the chamber dome and on the interior surface of the aluminium baseplate.Conclusion: based on the information provided by the customer and our investigation of the complaint device, the cause of the degradation is due the presence of sodium chloride solution in the mr290v chamber.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present 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.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent.".
 
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 base plate had a pin-hole and water was leaking through the pin-hole.The hospital further reported that nebulised drug diluted in saline solution was administered, and patient secretion and condensation in the breathing circuit was returned to the mr290v vented autofeed humidification chamber.It was also reported that the mr290v chamber was used for approximately 12 days.There were no patient consequences.
 
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Brand Name
VENTED HUMIDIFICATION CHAMBER
Type of Device
AUTOFEED CHAMBER
MDR Report Key11092530
MDR Text Key224835302
Report Number9611451-2020-01237
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,distri
Type of Report Initial,Followup
Report Date 12/03/2020
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 NumberMR290V
Device Catalogue NumberMR290V
Device Lot Number200826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/26/2021
Supplement Dates FDA Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2020
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
AEROGEN NEBULIZER ADAPTOR; AEROGEN NEBULIZER ADAPTOR; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT380 ADULT BREATHING CIRCUIT; F&P RT380 ADULT BREATHING CIRCUIT
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