MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-16 for OPTIFLOW JUNIOR 2 CANNULA OJR414 manufactured by Fisher & Paykel Healthcare Ltd.
[182357928]
(b)(4). We are in the process of obtaining further information and the complaint device for investigation. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[182357929]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the interface of an ojr414 optiflow junior 2 nasal cannula was torn, the patient was found entangled in it and was "choking itself". The hospital further informed f&p that the patient "is ok" and "no marks on the throat visible". No further patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611451-2020-00068 |
MDR Report Key | 9598292 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-01-16 |
Date of Report | 2019-12-19 |
Date of Event | 2019-12-19 |
Date Mfgr Received | 2020-02-24 |
Device Manufacturer Date | 2019-03-05 |
Date Added to Maude | 2020-01-16 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. FARANAK GOMAROONI |
Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
Manufacturer City | IRVINE, CA CA 92618 |
Manufacturer Country | US |
Manufacturer Postal | 92618 |
Manufacturer Phone | 9494534000 |
Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
Manufacturer City | AUCKLAND, 2013 |
Manufacturer Country | NZ |
Manufacturer Postal Code | 2013 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OPTIFLOW JUNIOR 2 CANNULA |
Generic Name | CAT |
Product Code | CAT |
Date Received | 2020-01-16 |
Model Number | OJR414 |
Catalog Number | OJR414 |
Lot Number | 2100716526 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-16 |