BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 INFORMATION CENTER LOCAL DATABASE

    MDR report key: 11695466 · Received April 20, 2021

    Report

    Report Number
    1218950-2021-10399
    Event Type
    Death
    Date Received
    April 20, 2021
    Date of Event
    March 19, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K050742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER. THE CUSTOMER REQUESTED ASSISTANCE IN OBTAINING LOST DATA FROM A DISCHARGED PATIENT. THE CUSTOMER INDICATED THAT THE USER MAY NOT HAVE HIT SAVE. DUE TO PATIENT DEATH, LOGS WERE NEEDED AS STAFF STATED USER CLAIM THERE WAS NO ALARMING AT THE TIME OF THE EVENT. A REMOTE CLINICAL APPLICATION SPECIALIST (CAS) SPOKE WITH THE CUSTOMER BIOMEDICAL ENGINEER (BME) AND FOUND THAT THE CUSTOMER WAS USING PIC CLASSIC WITH M4841A TELEMETRY WHICH IS OUT OF SUPPORT. THE BME INDICATED THAT THERE WAS A PATIENT DEATH AND THE CLINICAL USER NEEDED ASSISTANCE WITH RETRIEVING THE PATIENT HISTORY TO DETERMINE IF THE DEVICE ALARMED APPROPRIATELY OR THERE WAS ANY PRODUCT ISSUE. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ONSITE SERVICE. THE FSE COLLECTED THE SYSTEM LOGS AND CLINICAL AUDIT LOG. THE INCIDENT WAS ALLEGED TO OCCUR AT 6:30 AM ON (B)(6) 2021. THE CUSTOMER WAS UNABLE TO PROVIDE THE BED LABEL INFORMATION. THE LOGS WERE REVIEWED BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS). THE CPS COULD NOT VERIFY WHAT WAVES WERE VISIBLE AT THE PATIENT INFORMATION CENTER ON (B)(6) 2021 AS THE LOG WAS WRITTEN OVER. THERE WERE NO ALARM RECORDINGS AT THE REPORTED INCIDENT TIME OF 6:30 AM FOR ANY BED. THE REVIEW COULD NOT ESTABLISH ADMISSION STATE FOR THE PATIENT AS THERE WAS NO BED LABEL PROVIDED. THE CAUSE OF THE ALLEGED FAILURE TO ALARM COULD NOT BE DETERMINED. THE CUSTOMER INDICATED THAT THE USER MAY NOT HAVE SAVED THE PATIENT DATA AND WAS UNABLE TO SUPPLY BED LABEL INFORMATION FOR THE LOG REVIEW. THE REVIEW COULD NOT VERIFY AN ALARM EVENT AT 6:30 AM ON (B)(6) 2021. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO VERIFY WHETHER AN ALARM FAILED TO OCCUR.

    Description of Event or Problem · 0

    THE CUSTOMER REQUESTED ASSISTANCE IN OBTAINING LOGS RELATED TO A PATIENT DEATH. THE CUSTOMER ALLEGED THAT THERE WAS NO ALARMING AT TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED ASSISTANCE IN OBTAINING LOGS RELATED TO A PATIENT DEATH. THE CUSTOMER ALLEGED THAT THERE WAS NO ALARMING AT TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593954 M3150 INFORMATION CENTER LOCAL DATABASE M3150 INFORMATION CENTER LOCAL DATABASE MHX PHILIPS NORTH AMERICA LLC 862173 (M3150)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death