SURESIGNS VM6 : IBP 863065

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-13 for SURESIGNS VM6 : IBP 863065 manufactured by Philips Medical Systems.

Event Text Entries

[186132696] A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[186132697] The customer contacted the customer care solution center and alleged that the complaint device had failed to alarm and requested support. The complaint device was not in clinical use at the time that the issue was discovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01669
MDR Report Key9828822
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-13
Date of Report2020-02-28
Date Mfgr Received2020-02-28
Device Manufacturer Date2010-04-15
Date Added to Maude2020-03-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 VM6 : IBP
Generic NameNA
Product CodeMHX
Date Received2020-03-13
Model Number863065
Catalog Number863065
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 2020-03-13

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