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	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer submitted feedback via salesforce stating "machine formatting and insta support." additional information was requested to clarify the customer's issue.It was reported the monitor was locking and freezing image.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Additional Manufacturer Narrative
The customer care solution center dispatched a field service engineer (fse) for support.The cause of the monitor hanging was unknown.The fse performed somatization of the machine and completed reinstallation of software.The fse also performed follow up and support to it for the installation of the antivirus and insertion of the machine in the "beneficência.Org" domain.The issue was resolved by reinstalling the software.The device passed all the performance function testing.The device remains on site and in use at this customer site.No subsequent calls have been logged for this device/issue.

• 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: 15319289
• Report Number: 1218950-2022-00848
• Device Sequence Number: 12063688
• 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

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/30/2022
• 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