Device product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Z-0636-2024
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 93581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- n/a - no physical product
- Official record key
device-enforcement:Z-0636-2024
Official wording
Reason: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Code information: UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Distribution pattern: Domestic distribution nationwide.
Derived failure modes
-
Unknown
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature