BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10120917 · Received June 4, 2020

    Report

    Report Number
    1218950-2020-03279
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 2, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER NURSE. THE RCE RECEIVED INFORMATION THAT THE PATIENT WAS IN ROOM (B)(6) AND WAS PUT ON A "TRANSPORT" MONITOR, WHEN PATIENT HAD EPISODES OF BRADYCARDIA. THE RCE ASKED THE NURSE IF THE TRANSPORT MONITOR WAS ASSIGNED TO THE PHILIPS INFORMATION CENTER IX (PIC IX) IN ORDER FOR DATA TO BE STORED, AND THE NURSE WAS NOT SURE. THE RCE FOLLOWED-UP WITH THE CUSTOMER, AND SPOKE TO A DIFFERENT CUSTOMER NURSE, AFTER THE INITIAL REPORT. THERE WAS NO INJURY TO PATIENT OR EQUIPMENT MALFUNCTION, ACCORDING THE SECOND NURSE. THE ORIGINAL NURSE WAS LOOKING TO RETRIEVE DATA FROM THE PIC IX. THE RCE WAS ABLE TO AGAIN SPEAK TO THE ORIGINAL REPORTING NURSE, WHO CONFIRMED THAT THE PATIENT WAS PUT ONTO A "TRANSPORT" MONITOR CART AT APPROXIMATELY 9:45AM, BUT THE NURSE HAD NOT ADDED THE "TRANSPORT" DEVICE TO THE SECTOR, WHICH WOULD HAVE ALLOWED STORAGE OF PATIENT DATA DURING THE TIMEFRAME CU WAS LOOKING TO REVIEW. THE NURSE CONFIRMED UNDERSTANDING OF THE RCES EXPLANATION OF HOW DATA IS STORED AND THE IMPORTANCE OF ADDING DEVICES TO SECTORS. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ERROR, AS THE "TRANSPORT" DEVICE HAD NOT BEEN ADDED TO THE SECTOR TO ALLOW DATA STORAGE. THIS LEAD TO THE REPORTED MISSING PATIENT DATA. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER NURSE STATED THAT PATIENT DATA WAS MISSING FROM THE MX40 TELEMETRY DEVICE DURING TRANSPORT; THEY WERE NOT ABLE TO PULL UP THE PATIENTS VITAL DURING THE TRANSPORT OF THE PATIENT. THE NURSE STATED THE PATIENT WAS ATTACHED TO THE MX40 WHEN A CARDIAC ARREST HAPPENED. A SECOND NURSE INDICATED THERE WAS NO PATIENT HARM, IT IS UNCLEAR IF THERE WAS, OR WAS NOT, ACTUAL HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581177 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening