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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 Corroded (1131); Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2022
Event Type  malfunction  
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.
 
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 found to be leaking water during patient use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint device mr290v humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection confirmed that a hole was found on the base of the chamber.Additionally, a stain was found on the inside of the chamber dome and base.It was also reported that the customer had used nebulized drugs with the complaint chamber.Conclusion: based on the information provided by the customer, our investigation and previous investigations of similar complaints, the cause of the degradation is due the use of nebuliuzed drugs corrosive to the aluminium mr290v chamber base.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present 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.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent.".
 
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 found to be leaking water during patient use.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 Key15398089
MDR Text Key299695172
Report Number9611451-2022-00837
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 08/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2022
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 Number211122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received09/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2021
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
AEROGEN SOLO NEBULIZER; AEROGEN SOLO NEBULIZER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; SERVO-AIR VENTILATOR; SERVO-AIR VENTILATOR
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