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

Model Number	863352
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site and tested the device.The fse checked the central monitor cms200 and noted that some patient monitors were in audio off state.The fse simulated the monitor and disabled the audio off function and deemed the central monitor alarms visual and audible working as intended.The fse advised the user not to activate the audio off on the patient monitor.Results of functional testing indicate no device malfunction.Based on the information available and the testing conducted, the cause of the reported problem was caused by the user error in setting function.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported that there was no alarm on the central.The device was in use on a patient.There was no report of patient or user harm.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17540983
• Report Number: 1218950-2023-00563
• Device Sequence Number: 7570361
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: 00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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