BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CRITICAL CARE AND ANESTHESIA

    MDR report key: 24860704 · Received April 13, 2026

    Report

    Report Number
    9610816-2026-100694
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 7, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DXJ
    UDI-DI
    00884838113763
    PMA / PMN Number
    K151366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179009 INTELLISPACE CRITICAL CARE AND ANESTHESIA DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE CC & ANESTHESIA J 00884838113763

    Patients

    Seq Age Sex Outcome Treatment
    1