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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CMS200 CENTRAL MONITORING SYSTEM
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PHILIPS NORTH AMERICA LLC EFFICIA CMS200 CENTRAL MONITORING SYSTEM Back to Search Results
Model Number 863352
Medical Device Problem Code Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/02/2022
Type of Reportable Event Malfunction
Event or Problem Description
It was reported to philips that system hanging, live data not coming.The device was not in use on a patient at the time of event, there was no patient involvement.
 
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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 Key15240083
Report Number1218950-2022-00763
Device Sequence Number4693702
Product Code MHX
UDI-Device Identifier00884838058309
UDI-Public00884838058309
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K160951
Number of Events Summarized1
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 Number863352
Device Catalogue Number863352
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2022
Initial Report FDA Received Date08/17/2022
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured06/21/2019
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 Number1
Patient SexUnknown
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