VS4 VITAL SIGNS MONITOR 863283

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-19 for VS4 VITAL SIGNS MONITOR 863283 manufactured by Philips Medical Systems.

Event Text Entries

[183517120] Phone not provided. The customer replaced the speaker, front housing/display assembly, calibrated the touchscreen and tested the unit. This was not serviced by a philips employee and the customer has declined to provide any further information. The device remains at the customer site.
Patient Sequence No: 1, Text Type: N, H10


[183517121] The customer reported the problem of audio failed. Patient involvement is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01159
MDR Report Key9726904
Report SourceUSER FACILITY
Date Received2020-02-19
Date of Report2020-02-10
Date Mfgr Received2020-02-10
Device Manufacturer Date2013-02-01
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROBERT CORNING
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVS4 VITAL SIGNS MONITOR
Generic NamePATIENT MONITOR
Product CodeDXN
Date Received2020-02-19
Model Number863283
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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