RESPIRATORY HUMIDIFIER MR850

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-24 for RESPIRATORY HUMIDIFIER MR850 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187861235] (b)(4). The complaint mr850 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine the involvement of our product in the reported event. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10


[187861236] A healthcare facility in (b)(6) reported that a patient had an obstruction of the tracheal probe due to a "mucus block". The patient was setup on a mr850 respiratory humidifier system at the time of the event. There were no further reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00229
MDR Report Key9876216
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-24
Date of Report2020-02-17
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-24
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 DRIVE 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 NameRESPIRATORY HUMIDIFIER
Generic NameBTT
Product CodeBTT
Date Received2020-03-24
Model NumberMR850
Catalog NumberMR850
Lot NumberNOT PROVIDED
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
101. Other 2020-03-24

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