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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); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Further information has been requested from the healthcare facility.We are currently in the process of finalising our investigation and will provide a follow-up report on completion.
 
Event Description
A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative, that several events had occurred at their facility in which mr290v vented autofeed humidification chambers were found to be leaking during patient use.It was also reported that this was in association with administering nebulized drugs (atrovent, ventolin, combivent and iloprost) via a nebulizer attached at the chamber inlet port.This resulted in discoloration of the water within the chamber and corrosion of the aluminium chamber base.There was no reported patient consequence in association with these events.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and the photographs provided by the customer, and our knowledge of the product.Result: visual inspection of the provided photograph identified discoloration of the chamber water and crystallization on the outside of the chamber.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.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.".
 
Event Description
A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative, that several events had occurred at their facility in which mr290v vented autofeed humidification chambers were found to be leaking during patient use.It was also reported that this was in association with administering nebulized drugs (atrovent, ventolin, combivent and iloprost) via a nebulizer attached at the chamber inlet port.This resulted in discoloration of the water within the chamber and corrosion of the aluminium chamber base.There was no reported patient consequence in association with these events.
 
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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 Key15841430
MDR Text Key304198643
Report Number9611451-2022-01085
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeNL
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 Other
Type of Report Initial,Followup
Report Date 10/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
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 Number2101955872
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2021
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 NEBULIZER ADAPTER; AEROGEN NEBULIZER ADAPTER; F&P 950 RESPIRATORY HUMIDIFIER; F&P 950 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT
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