BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 19162760 · Received April 23, 2024

    Report

    Report Number
    1218950-2024-00287
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 10, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K143057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION THE REPORTED PROBLEM TURNED OUT TO BE NOT REPORTABLE ANALYSIS WAS PERFORMED AND INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THERE WAS NO MALFUNCTION IN PIC IX BECAUSE ALARM DID NOT GENERATE DUE TO THE CONFIGURATION OF THE MX400. THE PIC IX SYSTEM WAS WORKING AS INTENDED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND IDENTIFIED THAT A SECOND CASE WAS OPENED FOR THE MX400 BEDSIDE MONITOR. THE REPORTED ISSUE WITH THE MONITOR REPRESENTED A NO MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE DEVICE HAS BEEN RECEIVED BY PHILIPS FOR EVALUATION. E1: REPORTING INSTITUTION PHONE#:(B)(6). E1: REPORTER PHONE# (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE PATIENT INFORMATION CENTER IX RED ALARM RINGS IN YELLOW. IT IS KNOWN THAT THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE PATIENT INFORMATION CENTER IX RED ALARM RINGS IN YELLOW. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942807 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown