OPTIFLOW JUNIOR 2 CANNULA OJR412

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-13 for OPTIFLOW JUNIOR 2 CANNULA OJR412 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[183154989] (b)(4). We are currently attempting to retrieve the complaint device for evaluation. We will provide a follow up report upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10


[183154990] A healthcare facility in (b)(6) reported that the tubing of an ojr414 optiflow junior 2 nasal cannula was damaged during use. It was reported that the patient desaturated and recovered. There was no further patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00149
MDR Report Key9709786
Report SourceUSER FACILITY
Date Received2020-02-13
Date of Report2020-01-16
Date of Event2019-01-09
Date Mfgr Received2020-01-16
Date Added to Maude2020-02-13
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 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494534000
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 NameOPTIFLOW JUNIOR 2 CANNULA
Generic NameCAT
Product CodeCAT
Date Received2020-02-13
Model NumberOJR412
Catalog NumberOJR412
Lot Number2100868153
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 2020-02-13

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