BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITION

    MDR report key: 19780343 · Received July 19, 2024

    Report

    Report Number
    3003768277-2024-03960
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    July 6, 2024
    Report Date
    February 10, 2025
    Manufacturer
    PHILIPS INDIA LTD.
    Product Code
    OWB
    UDI-DI
    00884838091528
    PMA / PMN Number
    K183040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS FURTHER INVESTIGATED THIS COMPLAINT. AN ADDITIONAL REVIEW OF THE CLINICAL CASE AND MEDICAL LITERATURE WAS CARRIED OUT. THE REVIEW IDENTIFIED THAT THERE ARE THREE DIFFERENT TYPES OF EMERGENCY PROCEDURES WHERE ENDOSCOPY IS PERFORMED WITH FLUOROSCOPY IMAGING: GASTROINTESTINAL BLEEDING, ACUTE CHOLANGITIS/ACUTE BILIARY PANCREATITIS, AND FOREIGN BODY INGESTION. FOR ALL THREE TYPES OF PROCEDURES, IT WAS CONCLUDED BASED ON MEDICAL LITERATURE RESEARCH THAT, AS THE PROCEDURE WAS COMPLETED ON A DIFFERENT SYSTEM, THE LIKELIHOOD OF SERIOUS INJURY DUE TO THE DELAY IN AN EMERGENCY ENDOSCOPY WAS REMOTE. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR SERIOUS INJURY, AND THE COMPLAINT WAS REPORTED. SINCE THEN, NEW REVIEWS HAVE CONFIRMED THAT THE DELAY IN TREATMENT WOULD NOT LEAD TO A SERIOUS INJURY EVENT. THEREFORE, PHILIPS HAS REEVALUATED THIS COMPLAINT AS NOT REPORTABLE. CORRECTED DATA: ADVERSE EVENT/PRODUCT PROBLEM

    Additional Manufacturer Narrative · 0

    PHILIPS HAS FURTHER INVESTIGATED THIS COMPLAINT. AN ADDITIONAL REVIEW OF THE CLINICAL CASE AND MEDICAL LITERATURE WAS CARRIED OUT. THE REVIEW IDENTIFIED THAT THERE ARE THREE DIFFERENT TYPES OF EMERGENCY PROCEDURES WHERE ENDOSCOPY IS PERFORMED WITH FLUOROSCOPY IMAGING: GASTROINTESTINAL BLEEDING, ACUTE CHOLANGITIS/ACUTE BILIARY PANCREATITIS, AND FOREIGN BODY INGESTION. FOR ALL THREE TYPES OF PROCEDURES, IT WAS CONCLUDED BASED ON MEDICAL LITERATURE RESEARCH THAT, AS THE PROCEDURE WAS COMPLETED ON A DIFFERENT SYSTEM, THE LIKELIHOOD OF SERIOUS INJURY DUE TO THE DELAY IN AN EMERGENCY ENDOSCOPY WAS REMOTE. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR SERIOUS INJURY, AND THE COMPLAINT WAS REPORTED. SINCE THEN, NEW REVIEWS HAVE CONFIRMED THAT THE DELAY IN TREATMENT WOULD NOT LEAD TO A SERIOUS INJURY EVENT. THEREFORE, PHILIPS HAS REEVALUATED THIS COMPLAINT AS NOT REPORTABLE. (DEVICE) PROBLEM CODE GRID, PATIENT OUTCOME CODE GRID , HEALTH IMPACT CODE WAS CORRECTED. CORRECTED DATA: ADVERSE EVENT/PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, THE CUSTOMER WAS PERFORMING AN EMERGENCY ENDOSCOPY PROCEDURE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE, AND THAT THE PATIENT WAS UNCONSCIOUS AND INTUBATED AND PLACED IN INTENSIVE CARE. A PHILIPS FIELD SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE AND SYSTEM LOG FILES WERE ANALYZED. INVESTIGATION IDENTIFIED THAT THE LOSS OF SYSTEM FUNCTIONALITY WAS DUE TO A FAILURE OF THE ENERGY STORAGE UNIT (ESU) BATTERY. AFTER REPLACEMENT OF THE ESU BATTERY, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO ACQUIRE FURTHER INFORMATION ON THE REPORTED INCIDENT AND THE PATIENT OUTCOME. HOWEVER, THE CUSTOMER HAS NOT PROVIDED THE REQUESTED INFORMATION. AS PHILIPS HAS NOT RECEIVED ANY FURTHER INFORMATION ABOUT THE REPORTED INCIDENT AND THE PATIENT OUTCOME, PHILIPS IS UNABLE TO DETERMINE WHETHER THE PHILIPS SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING A FLUOROSCOPY EXAMINATION, THE SYSTEM LOST FUNCTIONALITY. THE CUSTOMER REBOOTED THE SYSTEM MULTIPLE TIMES WITHOUT RESOLVING THE ISSUE. THE PATIENT WAS LATER MOVED TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. IT WAS REPORTED TO PHILIPS THAT THE DELAY IN COMPLETION OF THE MEDICAL PROCEDURE MAY HAVE CONTRIBUTED TO THE POOR OUTCOME OF THE ENTIRE PROCEDURE; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED AS OF THE DATE OF THIS INITIAL REPORT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467149 ZENITION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS INDIA LTD. ZENITION 70 00884838091528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other