K171801

Substantially Equivalent

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: MHX
Advisory panel: Cardiovascular
Date received: 2017-06-16
Decision date: 2017-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boeblingen, DE

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.