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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 Problems Failure to Power Up (1476); Failure to Shut Off (2939)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that they were unable to turn on the device and that the monitor freezes up and is unable to turn off or get it going again. The device was not in use on a 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
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10454755
MDR Text Key205466976
Report Number1218950-2020-04945
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863283
Device Catalogue Number863283
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2020
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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