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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA

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PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA Back to Search Results
Model Number 866072
Device Problem No Display/Image (1183)
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.
 
Event Description
It was reported that the epidurmal order didn't display update after flow rate change from 8ml/h to 3ml/h.The error was noticed by the attending physician who discontinued the incorrect order that was displayed.The correct order was then administered to the patient.
 
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Brand Name
INTELLISPACE CC & ANESTHESIA
Type of Device
INTELLISPACE CC & ANESTHESIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key5383569
MDR Text Key36633253
Report Number1218950-2016-00475
Device Sequence Number1
Product Code DXJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K100272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/13/2016
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
Device Operator Health Professional
Device Model Number866072
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/13/2016
Initial Date FDA Received01/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/26/2016
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) Other;
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