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

Model Number 866148

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer alleged "in (b)(6) we have an issue that sometimes the patient medication infogrid is not filled correctly." no patient involvement.

• 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
• Manufacturer Contact: christopher mcdonough ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 11307863
• MDR Text Key: 232509835
• Report Number: 1218950-2021-00762
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 00884838075153
• UDI-Public: (01)00884838075153
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1