BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 22630256 · Received July 28, 2025

    Report

    Report Number
    1218950-2025-000426
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 12, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REMOTE CLINICAL SUPPORT (RCS) REVIEWED THE CLINICAL AUDIT LOG AND CONFIGURATION FILE. 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

    REMOTE CLINICAL SUPPORT (RCS) REVIEWED THE CLINICAL AUDIT LOG AND CONFIGURATION FILE. THE RCS CONFIRMED THAT THE CONFIGURATION WAS SET TO ALARM OFF OF SYSTOLIC ONLY AND THAT IS WHY WHEN THE MEAN DROPPED IT DID NOT ALARM. THIS IS CHANGED BY THE USER AS NEEDED BASED ON THE CLINICAL NEEDS TO MONITOR DIFFERENT PATIENTS. ALTHOUGH THE RCS REVIEWED THE AUDIT LOGS AND CONFIGURATION REMOTELY, THE COMPLETE LOG AND CONFIGURATION FILES WERE NOT DOWNLOADED OR RETAINED FOR THE RECORD. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS USER CONFIGURATION CHANGES. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED; HOWEVER, THE CUSTOMER WAS PROVIDED WITH INSTRUCTION TO ADJUST CONFIGURATION BASED ON THEIR CLINICAL NEEDS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE UNIT DID NOT ALARM FOR THE MEAN NBP WHEN IT WENT BELOW THE LIMIT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE DEVICE DID NOT GENERATE AN ALARM FOR LOW BLOOD PRESSURE. THE TELEMETRY PATIENT HAD A NITROGLYCERINE INFUSION RUNNING AND THEIR BLOOD PRESSURE DECREASED; HOWEVER, THE TELEMETRY TECHNICIAN INDICATED THERE WAS NO ALARM PRIOR TO NOTIFYING THE NURSE. THE PATIENT RECOVERED AND THE DROP IN PRESSURE WAS NOTED IN TIME. THE CUSTOMER REQUESTED ASSISTANCE COMPARING THE ALARMS IMPORTED TO CERNER WITH THE ALARMS IN THE CLINICAL AUDIT LOG. ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THERE WAS NO IMPACT TO THE PATIENT. NO ALARM WAS EXPECTED AS THE ALARM LIMITS HAD NOT BEEN VIOLATED AT THE TIME OF THE REPORTED ISSUE AND THE TELEMETRY TECHNICIAN NOTED THE PRESSURE DROP PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508572 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown