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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS EFFICIA CMS200 CENTRAL MONITORING SYSTEM; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS PHILIPS EFFICIA CMS200 CENTRAL MONITORING SYSTEM; PATIENT MONITOR Back to Search Results
Model Number 989803143171
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the monitor and central station are set to neonatal patients as default.When a patient is discharged at the central station it incorrectly shows the information adult - unknown patient.There was no reported patient incident or injury.
 
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Brand Name
PHILIPS EFFICIA CMS200 CENTRAL MONITORING SYSTEM
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6096059
MDR Text Key59969271
Report Number1218950-2016-07171
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K160951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/20/2016
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 Operator Health Professional
Device Model Number989803143171
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2016
Initial Date FDA Received11/11/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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