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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER
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FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290V
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will provide a follow-up report upon completion of our investigation.
 
Event Description
A distributor reported on behalf healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water during patient use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analyzed.Results: visual inspection of the returned complaint mr290 chamber revealed that the chamber dome flange had a deformation on one end.The chamber dome gasket was further observed with discolouration on the outer perimeter, and the diameter was smaller in comparison to a sample chamber dome gasket.Testing of the returned complaint chamber also revealed that water was leaking at the connection between the chamber dome and the chamber base.Conclusion: based on the investigation of the returned complaint device, it is likely that the complaint mr290v chamber was subjected to excessive heat.It is likely that the excessive heat caused the observed deformation of the chamber dome flange, and the discolouration and shrinkage of the chamber dome gasket.The physical changes observed may have weakened the seal between the chamber dome and chamber base, resulting in water leakage at the dome-base connection.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." - "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." - "do not fill the chamber with water in excess of 37c.".
 
Event Description
A distributor reported on behalf healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water during patient use.There was no reported patient consequence.
 
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Brand Name
VENTED 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
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key17295395
MDR Text Key318805516
Report Number9611451-2023-00611
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2023
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 NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2023
Was Device Evaluated by Manufacturer? Yes
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 RT202 ADULT BREATHING CIRCUIT; F&P RT202 ADULT BREATHING CIRCUIT
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