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	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged ¿level of the drug circuit for the syringe pump relays: traceability of erroneous administration with incorrect values of speed or name of drugs used totally wrong".The device was not in use on a patient.

• 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: 10029565
• Report Number: 1218950-2020-02698
• Device Sequence Number: 19515176
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: (01)00884838085565
• 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): 04/30/2020

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 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: 04/30/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1