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

Model Number	989803143171
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer contacted the customer care solution center and reported a speaker failure with the complaint device and requested support.The device was not in use on a patient.

• Brand Name: PHILIPS EFFICIA CMS200 CENTRAL MONITORING SYSTEM
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9233708
• Report Number: 1218950-2019-08137
• Device Sequence Number: 11537186
• Product Code: MHX
• UDI-Device Identifier: 00884838058309
• UDI-Public: (01)00884838058309
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K160951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 989803143171
• Device Catalogue Number: 863352
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1