MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0; CLINICAL INFORMATION MANAGEMENT SYSTEM

Model Number	866148
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All the patient accounts of (b)(6) were removed and the project of parameterization stopped.There was no malfunction of the device, this was use error in using the device.Philips attempted to obtain information regarding the patient, however it is unknown if the patient had any specific issue related to the inappropriate medication received.The patient was discharged and sent home.
Event or Problem Description
A patient received inappropriate medication order during customer intellispace critical care and anesthesia (icca) training session.It was stated that the philips clinical specialist was showing how to place an order in icca and thought she was on a test patient and placed the order on a real patient and the patient received the drug.They allege that the patient received medication that was incompatible with his state of health and endangered his life.It was reported that patient experienced harm.Additional information was requested however no new information concerning how the patient was harmed was received.

• 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 Key: 8779842
• Report Number: 1218950-2019-05019
• Device Sequence Number: 19327122
• Product Code: DXJ
• UDI-Device Identifier: 00884838075153
• UDI-Public: (01)00884838075153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1