MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EFFICIA CMS200 CENTRAL MONITORING SYSTEM

Model Number	CMS200
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an efficia cms200 central monitoring system indicating that the equipment locked and stopped working; it stopped monitoring intensive care unit (icu) beds.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
This complaint is a supplemental to 9610816-2024-000938 due to incorrect registration number used.Visual and functional testing was unable to be performed, as the device has not been returned for investigation.The cause of the reported problem was not able to be determined.The reported problem was not able to be confirmed.The investigation concludes that no further action is required at this time.If additional information is received, or if the device is returned, the complaint file will be reopened.Box e: reporting institution phone #: (b)(6).Reporter phone #:(b)(6).

• Brand Name: EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Common Device Name: EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 21663714
• Report Number: 1218950-2025-000158
• Device Sequence Number: 7564935
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: (01)00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMS200
• Device Catalogue Number: 863352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown