NON-VENTED HOSPITAL FULL FACE MASK RT046

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-20 for NON-VENTED HOSPITAL FULL FACE MASK RT046 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187410325] (b)(4). We are currently in the process of investigation. We will provide a follow up report upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10


[187410326] A distributor reported on behalf of a heatlhcare facility in (b)(6) that the headgear strap of rt046 non-vented hospital full face masks were torn during use. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00299
MDR Report Key9863021
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2020-03-20
Date of Report2020-02-21
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Date Added to Maude2020-03-20
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 TECHOLOGY DR. SUITE 100
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9194534000
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 NameNON-VENTED HOSPITAL FULL FACE MASK
Generic NameMNT
Product CodeMNT
Date Received2020-03-20
Model NumberRT046
Catalog NumberRT046
Lot NumberNOT PROVIDED
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 2020-03-20

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