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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2

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PHILIPS MEDICAL SYSTEMS SURESIGNS VS2 Back to Search Results
Model Number 863079
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the device's screen freezes on the start screen colors. There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.
 
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Brand NameSURESIGNS VS2
Type of DeviceSURESIGNS VS2
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6577959
MDR Text Key75624628
Report Number1218950-2017-03250
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K090483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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