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 2018-11-13 for ADULT TRACHE DIRECT INTERFACE OPT970 manufactured by Fisher & Paykel Healthcare Ltd.
[128198099]
(b)(4). The opt970 interface is used to deliver humidified oxygen to patients via tracheostomy. The interface is held in place by a neck strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's trache. We are currently in the process of following up with the hospital to retrieve further information and the complaint opt970 device. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[128198100]
A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the opt970 tracheostomy interface disconnected during use. The circuit had come off from the connector part of the opt970. We were further informed that patient was coughing intensely from time to time and it is possible that the opt970 broke as a result of the cough. The hospital informed our field representative that the patient was without humidification at the time of incident but no patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00971 |
| MDR Report Key | 8067833 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-13 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-11-13 |
| 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 |
| 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 TRACHE DIRECT INTERFACE |
| Generic Name | BZA |
| Product Code | BZA |
| Date Received | 2018-11-13 |
| Model Number | OPT970 |
| Catalog Number | OPT970 |
| 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 | 2018-11-13 |