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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER
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FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290VX
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2022
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 cracked and leaking water after 10 minutes of patient use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).The complaint mr290vx vented autofeed humidification chamber is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide 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 photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph of the mr290vx chamber revealed that the dome has long horizontal crack below the water level near the base.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.Every mr290vx 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 mr290vx 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 cracked and leaking water after 10 minutes of patient use.There was no patient consequence.
 
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Brand Name
VENTED AUTOFEED HUMIDIFICATION CHAMBER
Type of Device
AUTOFEED CHAMBER
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 Key16376471
MDR Text Key309649463
Report Number9611451-2023-00095
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 02/08/2023
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 NumberMR290VX
Device Catalogue NumberMR290VX
Device Lot Number2100797833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2023
Initial Date FDA Received02/14/2023
Supplement Dates Manufacturer Received06/06/2023
Supplement Dates FDA Received06/11/2023
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
Treatment
F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT
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