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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); Crack (1135); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2022
Event Type  malfunction  
Event Description
A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that the mr290v vented autofeed humidification chamber failed the pre-use leak test.Upon inspection, a large crack in the chamber dome was identified.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The complaint mr290v autofeed vented humidification chamber is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will send a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Correction to section d4: lot information updated.Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare for evaluation, where it was visually inspected.Results: visual inspection of the returned mr290v vented autofeed humidification chamber idenitifed a large vertical crack with stress marks near the bottom of the crack.Additionally, inspection found deformation to the chamber base.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it is likely due to transport damage.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.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.Our 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."."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 healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that the mr290v vented autofeed humidification chamber failed the pre-use leak test.Upon inspection, a large crack in the chamber dome was identified.There was no patient involvement.
 
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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 Key15290527
MDR Text Key298595605
Report Number9611451-2022-00784
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012431158
UDI-Public(01)09420012431158(10)2101892900(11)211117
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2022
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 Number2101892900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
F&P RT268 INFANT DUAL HEATED BREATHING CIRCUIT KIT; F&P RT268 INFANT DUAL HEATED BREATHING CIRCUIT KIT; SLE VENTILATOR; SLE VENTILATOR
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