ADULT NASAL INTERFACE OPT944

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-17 for ADULT NASAL INTERFACE OPT944 manufactured by Fisher & Paykel Healthcare Ltd.

MAUDE Entry Details

• Report Number: 9611451-2019-01216
• MDR Report Key: 9484701
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-12-17
• Date of Report: 2019-12-11
• Date of Event: 2019-10-28
• Date Mfgr Received: 2020-02-28
• Date Added to Maude: 2019-12-17
• 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: 9194534000
• 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

Device Details

• Brand Name: ADULT NASAL INTERFACE
• Generic Name: CAT
• Product Code: CAT
• Date Received: 2019-12-17
• Model Number: OPT944
• Catalog Number: OPT944
• Lot Number: 2100869718
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-12-17