MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CMS200 CENTRAL MONITORING SYSTEM

Model Number	863352
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	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the screen freezing and communication failure with bedside monitor.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the screen freezing and communication failure with bedside monitor.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.A philips field service engineer (fse) went onsite and confirmed the issue; the software application is locking.At the time of the diagnosis no defect was detected, but it was possible to check the central's error logs, there was a loss of communication with the license module and lost communication with the bedside monitors.During fse's visit no issue was found but fse noticed some logs involving license module disconnection.The fse performed functional testing and confirmed that the device was operating as intended.The device was returned to service/full functionality and remains in use at the customer site.

• Brand Name: EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Common Device Name: EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15321980
• Report Number: 1218950-2022-00852
• Device Sequence Number: 20305410
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Model Number: 863352
• Device Catalogue Number: 863352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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