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 2020-01-30 for VS4 VITAL SIGNS MONITOR 863283 manufactured by Philips Medical Systems.

Event Text Entries

[181626513] A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[181626554] The customer reported the problem of speaker malfunction and no audio tone heard. The device was not used on a patient at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-00716
MDR Report Key9650237
Report SourceUSER FACILITY
Date Received2020-01-30
Date of Report2020-01-28
Date Mfgr Received2020-01-28
Device Manufacturer Date2019-10-07
Date Added to Maude2020-01-30
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 Received2020-01-30
Model Number863283
Catalog Number863283
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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