VENTED 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 HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187426992] (b)(4). Method: the complaint devices mr290v vented autofeed humidification chamber were not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is based on the photographs provided by the customer and our knowledge of the product. Results: visual inspection of the photographs provided by the customer of the mr290v chambers confirmed cracks near the base of the chamber domes. Conclusion: from the information and photographs provided, we were unable to determine the cause of the chamber cracks. Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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. " "set appropriate ventilator alarms. " "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


[187426993] A distributor in (b)(4) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the mr290v vented autofeed humidification chambers were leaking water from the chamber base. There was no patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00323
MDR Report Key9887166
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-26
Date of Report2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-06-20
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 HUMIDIFICATION CHAMBER
Generic NameAUTOFEED CHAMBER
Product CodeBTT
Date Received2020-03-26
Model NumberMR290V
Catalog NumberMR290V
Lot Number191119, 190327
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.