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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 Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
Customer reported that drugs disappeared from the mar after placing the orders and then reappeared as "pending" orders.The device was in use on a patient.There was no report of patient or user harm.
 
Additional Manufacturer Narrative
There were no errors or messages stored in the icca event logs since the icca system will overwrite stored event logs after 24 hours.The customer was informed and was advised to contact philips immediately if there was a recurrence of the problem.
 
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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 Key10648849
Report Number1218950-2020-05964
Device Sequence Number19571982
Product Code DXJ
UDI-Device Identifier00884838075153
UDI-Public(01)00884838075153
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K100272
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 09/30/2020
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 09/30/2020
Supplement Date Received by Manufacturer09/30/2020
Initial Report FDA Received Date10/08/2020
Supplement Report FDA Received Date11/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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