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 2017-07-07 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.

Event Text Entries

[79401631] A follow up report will be submitted once the investigation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[79401632] The customer reported that vital signs from a previous patient case were charted on a current patient's anesthesia record in the or. There is a potential that incorrect stored vital sign data could be misinterpreted during care of the current patient. No patient harm has been reported.
Patient Sequence No: 1, Text Type: D, B5


[105794258]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2017-04432
MDR Report Key6694506
Date Received2017-07-07
Date of Report2017-06-23
Date Mfgr Received2017-06-23
Date Added to Maude2017-07-07
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 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 Report0

Device Details

Brand NameINTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Generic NameCLINICAL INFORMATION MANAGEMENT SYSTEM
Product CodeDXJ
Date Received2017-07-07
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 2017-07-07

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