Philips Efficia CMS200 Central Monitoring System— 510(k) K160951

Clearance details

Applicant

Philips Medical Systems

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2016-04-05

Decision date

2016-05-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Andover, MA, US

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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 →

• Z-1229-2017 — Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionalsClass II·Terminated·Philips Electronics North America Corporation·20170117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160951.