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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

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FISHER & PAYKEL HEALTHCARE LTD VENTED AUTOFEED 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 03/06/2023
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in china that a mr290v vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the photography and information provided by the customer, and our knowledge of the product.Results: visual inspection of the photo provided by the customer revealed water leak.Upon inspection, no cracks or damage on the chamber were observed.Conclusion: without the complaint device, we are unable to determine what may have caused the reported fault.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.The user instructions that accompany the mr290v vented autofeed humificiation 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."."do not use the chamber if the seals are not intact when received, or if it has been dropped.".
 
Event Description
A distributor reported on behalf of a healthcare facility in china that a mr290v vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.
 
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Brand Name
VENTED AUTOFEED 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 Key16679148
MDR Text Key312700977
Report Number9611451-2023-00297
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012430205
UDI-Public(01)09420012430205(10)2102262931(11)220714(17)270714
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/14/2023
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 Number2102262931
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/14/2023
Initial Date FDA Received04/04/2023
Supplement Dates Manufacturer Received04/11/2023
Supplement Dates FDA Received05/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2022
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 RT265 INFANT EVAQUA2 BREATHING CIRCUIT; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT
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