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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. SURESIGNS VS4 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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PHILIPS MEDICAL SYSTEMS, INC. SURESIGNS VS4 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2019
Event Type  malfunction  
Event Description
Two patients were admitted to neurosurgery and neurology service respectively. Portable vital sign monitor (vs4) in their semi-private patient's room was found to be smoking. Patients were unharmed and relocated to other rooms. It burned a hole in the privacy curtain.
 
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Brand NameSURESIGNS VS4
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd
andover MA 01810
MDR Report Key8619133
MDR Text Key145358226
Report Number8619133
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2019
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/15/2019
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer05/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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