INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148

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 2020-02-10 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.

Event Text Entries

[182470204] A follow up report will be submitted once the investigation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[182470205] The customer alleged "it has been reported again that the calories are not calculated correctly by propofol". No adverse event involving patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-00976
MDR Report Key9688208
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-10
Date of Report2020-02-03
Date Mfgr Received2020-02-03
Device Manufacturer Date2014-08-21
Date Added to Maude2020-02-10
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 ContactMS. BETTY HARRIS
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 NameINTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Generic NameCLINICAL INFORMATION MANAGEMENT SYSTEM
Product CodeDXJ
Date Received2020-02-10
Model Number866148
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 2020-02-10

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