SURESIGNS VS2+ NBP/SPO2 863278

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-04 for SURESIGNS VS2+ NBP/SPO2 863278 manufactured by Philips Medical Systems.

Event Text Entries

[185116197] A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[185116198] The customer reported audio failed error and speak is malfunctioning. The customer confirmed that the device was not connected to a patient when this event happened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01459
MDR Report Key9786995
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-04
Date of Report2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2013-07-22
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 NameSURESIGNS VS2+ NBP/SPO2
Generic NamePATIENT MONITOR
Product CodeDXN
Date Received2020-03-04
Model Number863278
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 2020-03-04

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