VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187425043] (b)(4). Method: the complaint mr290 humidification chamber was not returned to fisher & paykel healthcare for evaluation. Our investigation is based on the information and a photograph provided by the customer. Results: review of the photograph revealed that the water level was above the black water level line. Conclusion: without the return of the complaint device, we were unable to determine what caused the reported event. Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290 chamber being disabled. In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber but the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering into the breathing circuit. All mr290 chambers have float function and valve testing performed twice during production. A failure of any test would result in rejection of the chamber before distribution. The subject device would have met the specification at the time of production. The user instructions that accompany the mr290 humidification chamber specify in the warning section "do not use the chamber if the water rises above the maximum water level line" along with a diagram directing the user to check the water level on the chamber. A written description of the meaning of the symbols used is also included in the user instructions. It also states the following: "set appropriate ventilator alarm. " "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. "
Patient Sequence No: 1, Text Type: N, H10


[187425045] A distributor in (b)(6) reported on behalf of a healthcare facility to a fisher & paykel healthcare (f&p) field representative that an mr290v vented autofeed humidification chamber was overfilled immediately during normal use. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00329
MDR Report Key9881854
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-26
Date of Report2020-02-25
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-07-04
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DR. SUITE 100
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Manufacturer Phone4534000142
Manufacturer G1FISHER & PAYKEL HEALTHCARE LTD
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENTED AUTOFEED HUMIDIFICATION CHAMBER
Generic NameAUTOFEED CHAMBER
Product CodeBTT
Date Received2020-03-26
Model NumberMR290V
Catalog NumberMR290V
Lot Number190704
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LTD
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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