BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18255291 · Received December 4, 2023

    Report

    Report Number
    1218950-2023-00903
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 10, 2023
    Report Date
    July 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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

    THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPRODUCE THE PROBLEM DUE TO INSUFFICIENT INFORMATION NEEDED FOR COMPLETE ASSESSMENT. THE FSE COLLECTED THE LOGS AND CARRIED OUT TESTS ON THE CONTROL UNIT. THE ALARMS WERE CHECKED AND TESTS DETERMINED THE EQUIPMENT MEETS FACTORY SPECIFICATION. THE PRODUCT SUPPORT ENGINEER (PSE) CHECKED THE LOGS AND STATED THAT THERE IS NO WAY TO INVESTIGATE WITHOUT THE REQUIRED INFORMATION WHICH ALREADY HAS BEEN STATED BY THE FSE: ¿MISSING FUNDAMENTAL DATA TO ASSESS THE PROBLEM¿. MISSING INFORMATION INCLUDED DATE AND TIME OF THE EVENT, TELEMETRY SERIAL NUMBER AND THE PROVIDED SERIAL NUMBER WAS NOT PART OF THE SYSTEM BED/NAMES AND LABELS FOUND IN THE LOGS. PHILIPS WAS UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS RESTORED BACK TO USE. AS TESTS CARRIED OUT VERIFIED EQUIPMENT MEETS FACTORY SPECIFICATIONS. CORRECTED DATA: 510K IS K143057.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPRODUCE THE PROBLEM DUE TO INSUFFICIENT INFORMATION NEEDED FOR COMPLETE ASSESSMENT. HOWEVER, THE FSE CARRIED OUT TESTS ON THE CONTROL UNIT AND THE ALARMS WERE CHECKED, TESTS SHOW THE EQUIPMENT MEETS FACTORY SPECIFICATION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE PRODUCT SUPPORT ENGINEER (PSE) CHECKED THE LOGS AND CONCLUDED THAT THERE IS NO WAY TO INVESTIGATE WITHOUT THE REQUIRED INFORMATION WHICH WAS ALREADY INDICATED BY THE FSE. MISSING INFORMATION INCLUDES DATE AND TIME OF THE EVENT, TELEMETRY SERIAL NUMBER, AND THE BED CANNOT BE IDENTIFIED AS THE REPORTED BED IS NOT PART OF THE SYSTEM BED NAMES/LABELS. PHILIPS WAS UNABLE TO REPLICATE THE REPORTED PROBLEM. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. CORRECTED DATA: REVIEW OF RECORD INDICATED THE FOLLOWING REQUIRED CORRECTION: TYPE OF REPORTED COMPLAINT, MFG DATE, HEALTH IMPACT CODE, CONCLUSION CODE AND 510K. THE DESCRIPTION AND NARRATIVE WERE ALSO UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD AN EPISODE OF SYNCOPE BUT THERE WAS NO ALARM AT THE CENTRAL STATION. THE DEVICE WAS IN USE ON THE PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE BEHAVIOR OF THE DEVICE OR THE EFFECT ON THE PATIENT DUE TO THE EPISODE OF SYNCOPE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER INDICATING A PATIENT HAD AN EPISODE OF SYNCOPE BUT THERE WAS NO ALARM AT THE CENTRAL STATION. AS THE DEVICE FAILED TO ALARM FOR THE PATIENT IN SYNCOPE, THE PATIENT'S CHANGE IN CONDITION WAS NOT KNOWN; HOWEVER, THE PATIENT OUTCOME REMAINS UNKNOWN. AS THE ALARM WAS NOT TRIGGERED, IT CAN BE INTERPRETED THAT THE CAREGIVER WAS UNAWARE OF THE CHANGE IN CONDITION AND CARE WAS NOT RENDERED; THEREFORE, THE SYNCOPE MAY HAVE CONTINUED, WHICH IS HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604611 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other