MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE CRITICAL CARE AND ANESTHESIA; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number	INTELLISPACE CC & ANESTHESIA J
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).This mdr is submitted for a reportable malfunction identified during internal evaluation of device revision rev j.05, which is not commercially distributed.No units of rev j.05 have been released to the market.The currently commercially available version of the device is rev h.Because rev j.05 is not in commercial distribution, suspect product details including the 510(k) number and manufacturer name provided in this report are based on rev h, which represents the marketed configuration of the device.The identified malfunction is considered potentially applicable to the commercially distributed configuration if it were to occur in the field.No patient harm or serious injury has been reported.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that icca lab results had an issue regarding inbound interface involving the handling of updated specimen collection timestamps sent from the laboratory information system (lis).When a biologist modified the sample date and time (obr 7), the lis generated a new hl7 oru^r01 message using the same unique specimen identifier (obr 3.1) but with a corrected timestamp in obr 7 or obx 14.Icca did not update the previously stored sample date/time for that specimen; instead, it updated only the chart time field while continuing to display the result under the original chart time column in the lab flowsheet.This behavior prevents the result from being repositioned according to the corrected timestamp and may lead to misinterpretation of laboratory data timing, posing a potential patient safety risk.However, there was no harm to the patient.No additional information was provided by the customer.
Additional Manufacturer Narrative
A clinical and functional evaluation confirmed that corrected laboratory timestamps for an existing specimen id are not reflected in the flowsheet chart position, leading to inaccurate temporal display.Laboratory data integrity is not affected.No new clinical hazards were identified, and the residual risk remains acceptable.However, the issue is classified as device malfunction and a fix has been identified and will be implemented in a future software release, with customer notification and training planned.No further action is required at this time.Section d.2b: this submission corrects the ¿common device name¿ in initial emdr to display, cathode-ray tube, medical.Section g.3: this submission corrects the ¿date received by manufacturer¿ in initial emdr to 27 february 2026.

• Brand Name: INTELLISPACE CRITICAL CARE AND ANESTHESIA
• Common Device Name: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 24860704
• Report Number: 9610816-2026-100694
• Device Sequence Number: 9271670
• Product Code: DXJ
• UDI-Device Identifier: 00884838113763
• UDI-Public: (01)00884838113763(10)J.05.01
• 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,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INTELLISPACE CC & ANESTHESIA J
• Device Catalogue Number: 866148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown