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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED REUSABLE HUMIDIFICATION CHAMBER; BTT

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FISHER & PAYKEL HEALTHCARE LIMITED REUSABLE HUMIDIFICATION CHAMBER; BTT Back to Search Results
Model Number MR370
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2022
Event Type  malfunction  
Event Description
A healthcare facility in china reported that a mr370 reusable humidification chamber was found leaking water during patient use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr370 reusable humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a mr370 reusable humidification chamber was found leaking water during patient use.Conclusion: without the complaint device, we are unable to draw any reasonable conclusions about the reported event.All mr370 chambers are visually inspected before leaving the production line and those that fail are rejected.The subject mr370 chamber would have met the required specification at the time of production.Our user instructions that accompany the mr370 reusable humidification chamber state the following: "the following solutions should be avoided as they may cause the chamber to crack: ketones, formaldehyde, chlorinated hydrocarbons, hypochlorite, inorganic acids, aromatic hydrocarbons, phenol (>5%)." "to prevent cracking, ensure that the water inlet port plug, and any other reusable components, are disconnected from the chamber before cleaning.".
 
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Brand Name
REUSABLE HUMIDIFICATION CHAMBER
Type of Device
BTT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
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 Key16344601
MDR Text Key309303685
Report Number9611451-2023-00085
Device Sequence Number1
Product Code BTT
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
Reporter Occupation Other
Type of Report Initial
Report Date 01/16/2023
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 NumberMR370
Device Catalogue NumberMR370
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/16/2023
Initial Date FDA Received02/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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