K031433

Substantially Equivalent

SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS

Applicant: Siemens Medical Solutions USA, Inc.
Product code: DSI
Advisory panel: Cardiovascular
Date received: 2003-05-06
Decision date: 2003-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.