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

Model Number 866148

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer alleged calculations were not functioning.All the patients records on intellispace critical care and anesthesia (icca) from 21/11/2019 until the icca server restart on 25/11/2019 were affected.The device was in clinical use at the time the issue was discovered.There was no report of any adverse event or patient harm.

Manufacturer Narrative

Additional information was received that 35 icca patients (including 2 patients that were re-admitted) were affected from (b)(6) 2019 until the icca server restart on (b)(6) 2019.The patient demographic details were requested and provided for only 1 of the 35.Patients.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
• Type of Device: CLINICAL INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9440881
• MDR Text Key: 176248561
• Report Number: 1218950-2019-09286
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 00884838075153
• UDI-Public: (01)00884838075153
• Combination Product (y/n): N
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 75