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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 Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2023
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was leaking water during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).The complaint (b)(4) vented autofeed humidification chamber is currently en route to fisher & paykel healthcare.We will provide a follow up report upon completion of our investigation.
 
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was leaking water during 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 analysed.Results: visual inspection of the returned mr290v chamber revealed that the base was deformed at one location only.A mark caused by mechanical force was identified at the deformed location.The chamber was filled with water manually and pressurized with flow, no water leakage was observed.Rolled base thickness was measured on 4 sides, one of the measurements was out of specification.The out-of -specification measurement was located on the deformed side.Conclusion: we are unable to confirm the reported fault and determine the root cause of the reported event.However, our investigation indicates that the mark is most likely due to mechanical force and handling issue.Every mr290v 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.Also, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chamber would have met the required specification at the time of production.The 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." "do not use the chamber if the seals are not intact when received, or if it has been dropped.".
 
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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 Key16448823
MDR Text Key310336332
Report Number9611451-2023-00141
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 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMR290V
Device Catalogue NumberMR290V
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2023
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 RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT
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