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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 No Display/Image (1183)
Patient Problems Death (1802); Cardiogenic Shock (2262); Multiple Organ Failure (3261)
Event Date 11/10/2015
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer has alleged a potential safety issue regarding a drug dosage (amiodarone) in a standard order did not display.The patient had severe cardiogenic shock and was in multi organ failure and died a few days later.
 
Manufacturer Narrative
 
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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
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key5242289
MDR Text Key31801076
Report Number1218950-2015-06331
Device Sequence Number1
Product Code DXJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number866148
Device Lot Number1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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