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

Model Number	863352
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the nurse station did not alarm.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: (b)(6).A philips authorized service provider (asp) looked into the matter, and it was requested by the customer that philips download the device logs.The asp, in the process of retrieving the logs onsite to download, discovered the nurse station had no speaker connected at all.The asp noted the customer was not responsible for the speaker being left disconnected.Based on the information available and provided by the philips asp, the cause of the reported problem was that no speaker was connected.With the customer's help, the speaker was connected once again and the device returned to working specification.No further investigation or action is warranted at this time.

• 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: 21684631
• Report Number: 1218950-2025-000180
• Device Sequence Number: 8820107
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: (01)00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 863352
• 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: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• 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