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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 that a patient using prescribed drug epinephrine was assigned "infusing 18 ml / h and after a while the patient de-allocates himself and then appears as a proposal for norepinephrine, which already has [patient] pump".There was no reported patient 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
MDR Report Key10145680
Report Number1218950-2020-03402
Device Sequence Number2911780
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 06/04/2020
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 Health Professional
Device Model Number866148
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/04/2020
Supplement Date Received by Manufacturer06/04/2020
Initial Report FDA Received Date06/11/2020
Supplement Report FDA Received Date07/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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