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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 MR290VX
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2022
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in china that a mr290vx vented autofeed humidification chamber was found to be leaking water during patient use.It was reported that the leak location was between the chamber dome edge and base.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will send a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290vx vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photographs revealed a water was found leaking.Further inspection revealed that it is unclear where the water was leaking from as there is no visible damage was observed.Conclusion: without the complaint device, we are unable to determine what had caused the reported event.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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 mr290 chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290vx 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.".
 
Event Description
A distributor reported on behalf of a healthcare facility in china that a mr290vx vented autofeed humidification chamber was found to be leaking water during patient use.It was reported that the leak location was between the chamber dome edge and base.There was no 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 Key15974479
MDR Text Key305510208
Report Number9611451-2022-01186
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,Health Professional,User Facility,Distributor
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMR290VX
Device Catalogue NumberMR290VX
Device Lot Number2101782121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2021
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 RT226 INFANT VENTILATOR BREATHING CIRCUIT; F&P RT266 INFANT EVAQUA2 BREATHING CIRCUIT
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