MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE AND ANESTHESIA; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number	INTELLISPACE CC & ANESTHESIA J
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).This mdr is submitted for a serious injury reported by the customer.However, it was concluded by philips that the incident had occurred due to the user error.The reported issue has been reviewed and concluded that icca has no malfunction, and it was a device handling issue.Therefore, icca did not contribute to unconfirmed patient health impact.Thus, the reported event is concluded as conservatively reportable.
Event or Problem Description
It was reported that it is difficult to chart allergy in icca and moreover the display is truncated.If there are several allergies documented, it displays 3 dots but not all the content.In configuration, allergy intervention is hardcoded and there is no possibility to add allergy and intolerance with different documentation inside.A patient's planned surgery was cancelled and rescheduled due to the fact that a latex allergy was not seen (display truncated).No actual harm is reported however, an adverse event for patient is described as a type of harm.Later, it was confirmed that there was no harm to the patient.Medical attention and preventive medical attention both are marked as yes but information about medical condition was not provided.Good faith efforts were made to get more information about medical attention and preventive medical attention, but further information could not be received.No further information is available.

• Brand Name: INTELLISPACE CRITICAL CARE AND ANESTHESIA
• Common Device Name: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• 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: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 25084157
• Report Number: 1218950-2026-100289
• Device Sequence Number: 13394937
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: (01)00884838085565(10)J.01.02
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: INTELLISPACE CC & ANESTHESIA J
• Device Catalogue Number: 866148
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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: Required Intervention
• Patient Sex: Unknown