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	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/19/2024
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 allergy intervention is hard coded in icca.There is no possibility to insert allergy and intolerance with different documentation inside.The customer is not happy with it because it is too complex to fill.It is also mentioned that, it cannot be replaced in patient chart by an other intervention.If user fill another intervention (without reminders), the critical information of allergy would not be seen.Though patient harm is not reported, anaphylactic shock is provided as impact to the patient.An attempt has been made to confirm the impact to the patient but no further information was provided by the customer.

• 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: 25083979
• Report Number: 1218950-2026-100286
• Device Sequence Number: 13405379
• 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: 09/24/2024
• 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: Other
• Patient Sex: Unknown