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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR PATIENT MONITOR Back to Search Results
Model Number 863283
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that the vs4 had a speaker malfunction inop message and failed the audio test. 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 NameVS4 VITAL SIGNS MONITOR
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6581532
MDR Text Key75823156
Report Number1218950-2017-03302
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863283
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 Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2013
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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