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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS DIGITAL MONITOR FDA APPROVED FOR PATHOLOGY SIGN OUT; WHOLE SLIDE IMAGING SYSTEM
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS DIGITAL MONITOR FDA APPROVED FOR PATHOLOGY SIGN OUT; WHOLE SLIDE IMAGING SYSTEM Back to Search Results
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Headache (1880)
Event Date 05/11/2020
Event Type  Injury  
Event Description
This report is to draw attention to an issue with the phillips monitor which is fda approved for digital pathology sign out.Our department is implementing this but the monitor is entirely too bright.I have prior eye issues and must have a dimmer light source.Phillips has been entirely uncooperative in providing a solution to this problem and will not provide instructions on how to decrease the brightness of the monitor.I have had to discontinue the use of the monitor due to continued headache and eye strain.I cannot imagine i am the only pathologist on the planet with this issue so phillips really needs to be more attuned to this; retina burning brightness.Fda safety report id# (b)(4).
 
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Brand Name
PHILIPS DIGITAL MONITOR FDA APPROVED FOR PATHOLOGY SIGN OUT
Type of Device
WHOLE SLIDE IMAGING SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MDR Report Key10108713
MDR Text Key193617992
Report NumberMW5094775
Device Sequence Number1
Product Code PSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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