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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 Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a speaker malfunction error and that there was no audible sound. The device was not in clinical use at the time the reported issue was discovered.
 
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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 Key11029405
MDR Text Key222409171
Report Number1218950-2020-07910
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2014
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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