BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 11004253 · Received December 14, 2020

    Report

    Report Number
    1218950-2020-07758
    Event Type
    Death
    Date Received
    December 14, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 10, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10:A PHILIPS REMOTE SERVICE ENGINEER (RSE) RECEIVED A CALL BACK FORM THE CUSTOMER NURSE MANAGER. THE NURSE MANAGER EXPLAINED THAT THE M4841 TELEMETRY DEVICE WAS NOT ACTUALLY USED WITH THE PATIENT, AND THEY DID NOT ADMIT THE PATIENT INTO THE PHILIPS PIC IX SYSTEM. THE PATIENT WAS ACTUALLY HARDWIRED TO A NON-PHILIPS DEVICE, AND THEY WILL NOT NEED AN INVESTIGATION FROM PHILIPS AT THIS TIME. FURTHER INFORMATION WAS REQUEST FOR THE TYPE OF DEVICE, BUT NO FURTHER DETAILS WERE RECEIVED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3 OTHER TEXT : CUSTOMER CALLED STATING A PHILIPS DEVICE WAS NOT IN USE FOR THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2020, A PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. THE PATIENT WAS ASSIGNED TO TELE #11 IN RM 202 IN THE MED/SURG UNIT. THE CUSTOMER REPORTED HAVING TROUBLE WITH MAINTAINING THE ECG RHYTHM ON A PHILIPS INFORMATION CENTER IX (PIC IX) / M4841 TELEMETRY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466682 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death