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	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the efficia cms200 central monitoring system indicating a speaker error.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.
Additional Manufacturer Narrative
A philips technical support specialist (tss) remotely interviewed the customer who was onsite.The tss confirmed with the customer the device did not produce audible sound.The tss advised the customer to check the speaker cable.The customer identified the speaker cable was disconnected from the pc.After the speaker cable was connected to the pc, the device was returned to functional use with no further issues identified.H3 other text : see h10.

• Brand Name: EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Common Device Name: 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17690641
• Report Number: 1218950-2023-00625
• Device Sequence Number: 6531694
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: 00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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