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 with the FDA on 2019-02-06 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.

Event Text Entries

[135503559] A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[135503560] Antibiotic cefotaxime did not show in the icca worklist resulting in a delay in an administration. The customer has stated the medication was prescribed in the usual way but it did not generate scheduling and then did not appear in the work list and the patient did not receive antibiotics. After copying and updating the frequency, the order then appeared. There was no report of any adverse patient affect.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2019-01051
MDR Report Key8311228
Date Received2019-02-06
Date of Report2019-01-31
Date Mfgr Received2019-01-31
Device Manufacturer Date2012-04-16
Date Added to Maude2019-02-06
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 Report0

Device Details

Brand NameINTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Generic NameCLINICAL INFORMATION MANAGEMENT SYSTEM
Product CodeDXJ
Date Received2019-02-06
Model Number866148
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-06

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