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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
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.(b)(6).
 
Event Description
The customer alleged "it has been reported again that the calories are not calculated correctly by propofol".No adverse event involving patient or user was reported.
 
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Brand Name
INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Type of Device
CLINICAL INFORMATION MANAGEMENT SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9688208
MDR Text Key182470204
Report Number1218950-2020-00976
Device Sequence Number1
Product Code DXJ
UDI-Device Identifier00884838075153
UDI-Public(01)00884838075153
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K100272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866148
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/21/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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