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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone failed electronic submission (b)(6).A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the report miscalculates the amount of drug injected.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: 10522083
• Report Number: 1218950-2020-05290
• Device Sequence Number: 11410798
• Product Code: DXJ
• UDI-Device Identifier: 00884838093973
• UDI-Public: (01)00884838093973
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K100272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1