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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 when a doctor prescribes fentanyl via transdermal route (patch with the following dosage: 100 g/h) in "discontinue order" category, it is not possible to choose a dose in g/h.Thus, the user has to write the dose contained in the patch which is not clear because for example he will write ¿16.8 mg¿ to translate ¿100 g/h during 72 h.No adverse event involving patient or user was reported.
 
Additional Manufacturer Narrative
Clinical application specialist explained how to configure the drug properly to answer the customer request.
 
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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 Key9797285
Report Number1218950-2020-01510
Device Sequence Number16283985
Product Code DXJ
UDI-Device Identifier00884838093973
UDI-Public(01)00884838093973
Combination Product (Y/N)N
Initial Reporter CountryFR
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 Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/02/2020
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 03/02/2020
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date03/06/2020
Supplement Report FDA Received Date03/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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