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 2020-01-11 for ADULT NASAL INTERFACE OPT944 manufactured by Fisher & Paykel Healthcare Ltd.
[181923740]
(b)(4). We are also in the process of obtaining further information from the customer for investigation. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[181923741]
A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the prongs of an opt944 optiflow adult nasal cannula broke at the tubing connection during use. It was reported that there was patient harm. We are currently in the process of retrieving more information on the patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00047 |
| MDR Report Key | 9579091 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-11 |
| Date of Report | 2019-12-12 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-01-11 |
| 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 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 |
| Brand Name | ADULT NASAL INTERFACE |
| Generic Name | CAT |
| Product Code | CAT |
| Date Received | 2020-01-11 |
| Returned To Mfg | 2020-01-09 |
| Model Number | OPT944 |
| Catalog Number | OPT944 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2020-01-11 |