International safety notice
Updated Alert 2825 (Techno Surveillance) - Edwards - EV1000NI and EV1000A Clinical Platform Critical Care Monitor Possibility of fluid entering the AC power outlet of the EV1000A power adapter and EV1000NI pump unit.
Brazil / Anvisa · BRA · Mar 20, 2019
Key facts
| Title | Updated Alert 2825 (Techno Surveillance) - Edwards - EV1000NI and EV1000A Clinical Platform Critical Care Monitor Possibility of fluid entering the AC power outlet of the EV1000A power adapter and EV1000NI pump unit. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: EV1000NI Clinical Platform (80219050157); Technical Name: Cardiac Output Monitor (80219050157); ANVISA registration number: 80219050157; Product type: Equipment Risk Class: III Affected model: EVPMP (80219050157); Affected serial numbers: All batches of products with models EVPMP (80219050157) and EV1000A (80219050127) are affected. Update: Company action plan. Access the full content of Alert 2825 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICOCIRÚRGICOS LTDA CNPJ 05944604000100 RUA VERBO DIVINO 1547 1º ANDAR CJS 101102 SÃO PAULO SÃO PAULO TEL 1155675233 EMAIL CORABELZONIEDWARDSCOM FABRICANTE DO PRODUTO EDWARDS LIFESCIENCES LLC ONE EDWARDS WAY IRVINE CALIFORNIA 926145686 ESTADOS UNIDOS |
| Models | 80219050127, EV1000A, 80219050157, EV1000NI |
| Date | Mar 20, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 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