MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA

Model Number	866148
Medical Device Problem Code	Application Program Problem: Medication Error (3198)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation showed that the physician/user had changed the order resulting in the removal of the medication administration schedule.The order was then saved with the missing administration schedule resulting in the medication not being provided to the patient as expected by the nursing staff.Because the schedule was manually removed in the order, the medication schedule was not displayed in the administration record, medication overview or worklist for the nurse to review and include in the daily plan of care for the patient.This situation resulted in the patient not receiving the antibiotic medication regime for their medical situation.This clinical situation is a user error in which the user removed the pending scheduled administrations from the medication order unaware that the medication is pending administration.The reminders notification for the medication, such as overdue or pending are not issued by the software because the schedule does not exist.In the instructions for use id (b)(4) orders management chapter (page 6-17) the user is provided with a warning that whenever the user modifies a medication order, they will be prompted to review and approve the changes and their effect on the medication administration schedule.The device was operational.The investigation identified customer error and further action has been initiated.Internal enhancement request was entered to add additional warning of consequences when the user chooses to remove schedule.
Event or Problem Description
The customer reported that the intellispace cc & anesthesia indicating that prescription on icca software on 21/04 of levofloxacin does not appear in the nursing care plan.The device was in use at time of event, an adverse event was reported.

• Brand Name: INTELLISPACE CC & ANESTHESIA
• Common Device Name: INTELLISPACE CC & ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17119978
• Report Number: 1218950-2023-00409
• Device Sequence Number: 7200524
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Device Model Number: 866148
• Device Catalogue Number: 866148
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown