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

Model Number	CMS200
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).A philips technical support specialist (tss) went onsite to evaluate the device in question.The customer's alleged malfunction was confirmed.The tss troubleshooted by inspecting the control panel and correcting the audio output.There was short-term network outages noticed.The tss deactivated the ipv6 protocol and replaced the network cable unshielded twisted pair (utp) at the monitoring center to resolve the issue.Based on the information available and the testing conducted, the cause of the reported problem was confirmed network cable at the monitoring center.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.
Event or Problem Description
It was reported there was no audio by speaker.The device was in use on a patient at the time of the event.

• Brand Name: EFFICIA CMS200
• 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: 23327584
• Report Number: 1218950-2025-000607
• Device Sequence Number: 13246419
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: (01)00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 10/17/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown