MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC 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	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the device does not mirror image, and there was no audio alarm.The device was not in clinical use at the time the issue was discovered.There was no patient involvement.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the device does not mirror image, and there was no audio alarm.The device was not in clinical use at the time the issue was discovered.There was no patient involvement.
Event or Problem Description
It was reported to philips that the device does not mirror image, and there was no audio alarm.The device was not in clinical use at the time the issue was discovered.There was no patient involvement.

• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13479671
• Report Number: 1218950-2022-00106
• Device Sequence Number: 5147458
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 08/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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