International safety notice
Alert 2057 (Technosurveillance) Update - Announcement from the company Magnamed Tecnologia Médica - Pulmonary Ventilator Patient ventilation failures.
Brazil / Anvisa · BRA · Jun 30, 2016
Key facts
| Title | Alert 2057 (Technosurveillance) Update - Announcement from the company Magnamed Tecnologia Médica - Pulmonary Ventilator Patient ventilation failures. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Lung Ventilators. Technical name: Pressure and Volume Ventilator. ANVISA registration number: 80659160003. Product type: Medical Equipment. Risk class: III High Risk. Affected models: 1103050- FLEXIMAG - ELECTRONIC LUNG VENTILATOR NEONATAL PEDIATRIC ADULT 10.4POL (ANVISA Registration 80659160003, class III); Access the Technovigilance Panels through the link https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoes-analiticas/tecnovigilancia and the full content of Alert 2057 with the respective attachments on the ANVISA website (https ://www.gov.br/anvisa/pt-br/alertas). |
| Manufacturer | EMPRESA FABRICANTE E DETENTORA DO REGISTRO MAGNAMED TECNOLOGIA MÉDICA SA CNPJ 01298443000173 R DESEMBARGADOR ELISEU GUILHERME 292 5º E 6º ANDAR PARAÍSO SÃO PAULOSP TELEFONE 1150814115 EMAIL MAGNAMEDMAGNAMEDCOMBR |
| Models | 1104970, 1103050, 80659160003, 15POL, 1103760 |
| Date | Jun 30, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1