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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0; CLINICAL INFORMATION MANAGEMENT SYSTEM
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PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0; CLINICAL INFORMATION MANAGEMENT SYSTEM Back to Search Results
Model Number 866148
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event or Problem Description
The customer alleged "no medication was transferred from a silicon patient to intellispace critical care and anesthesia (icca)".The device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Common Device Name
CLINICAL INFORMATION MANAGEMENT SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9624993
Report Number1218950-2020-00561
Device Sequence Number11481041
Product Code DXJ
UDI-Device Identifier00884838075153
UDI-Public(01)00884838075153
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K100272
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number866148
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2020
Supplement Date Received by Manufacturer01/14/2020
Initial Report FDA Received Date01/23/2020
Supplement Report FDA Received Date02/14/2020
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/08/2016
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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