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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 Defective Device (2588)
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 faulty speaker - audio. No patient involvement.
 
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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
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8645248
MDR Text Key146261565
Report Number1218950-2019-03841
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884838087095
UDI-Public(01)00884838087095
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,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863283
Device Catalogue 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 Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2018
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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