BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 12544682 · Received September 28, 2021

    Report

    Report Number
    1218950-2021-10964
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 3, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WANTS CLINICAL AUDIT LOG DATA PULLED FOR THE PATIENT THAT EXPIRED DUE TO CARDIAC ARREST IN ROOM 264T BETWEEN (B)(6) 2021 23:08 AND (B)(6) 2021 00:00 TO INVESTIGATE THE ECG LEADS OFF NOTATION AND WHY THERE WAS NO RESPONSE BY STAFF.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WANTS CLINICAL AUDIT LOG DATA PULLED FOR THE PATIENT THAT EXPIRED DUE TO CARDIAC ARREST IN ROOM (B)(6) BETWEEN (B)(6) 2021 23:08 AND (B)(6) 2021 00:00 TO INVESTIGATE THE ECG LEADS OFF NOTATION AND WHY THERE WAS NO RESPONSE BY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442217 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS NORTH AMERICA LLC 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death