BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 15614909 · Received October 17, 2022

    Report

    Report Number
    9610816-2022-00523
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    September 19, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838000438
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : NO ALLEGED PRODUCT MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REQUESTED DOCUMENTING CONCERNING (B)(4) OR SERVICE HISTORY OF A FCO BEING APPLIED TO THE DEVICE IN QUESTION. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) PROVIDED ANOTHER FCO (B)(4) IN WHICH THE SERIAL NUMBER WAS LISTED ON THE CAN APPLICATION LAYER (CAL). A PHILIPS REGIONAL SERVICE MANAGER (RSM) FOLLOWED UP WITH CUSTOMER, AND TOLD THEM PHILIPS WILL CONTINUE TO RESEARCH THE REQUEST AND THAT THE INITIAL FCO WAS FOR AN ADDENDUM TO THE INSTRUCTION FOR USE IFU. AT THE TIME OF THE FOLLOW-UP, THE CUSTOMER INDICATED THEY WANTED TO BE TRANSPARENT THAT THE REASON WHY THEY ARE ASKING FOR THE DOCUMENTATION WAS DUE TO PENDING LITIGATION. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE. THE REPORT WAS MARKED AS PATIENT HARM. THE NATURE OF THE HARM WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    AFTER FURTHER INVESTIGATION, THIS COMPLAINT WAS DEEMED NOT A REPORTABLE EVENT WITH PHILIPS. THE CUSTOMER REQUESTED DOCUMENTATION CONCERNING FCO86201075A OR SERVICE HISTORY OF A FCO BEING APPLIED TO THE DEVICE IN QUESTION. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) PROVIDED ANOTHER FCO 86201218A IN WHICH THE SERIAL NUMBER WAS LISTED ON THE CAN APPLICATION LAYER (CAL). A PHILIPS REGIONAL SERVICE MANAGER (RSM) FOLLOWED UP WITH CUSTOMER, AND TOLD THEM PHILIPS WILL CONTINUE TO RESEARCH THE REQUEST AND THAT THE INITIAL FCO WAS FOR AN ADDENDUM TO THE INSTRUCTION FOR USE IFU. AT THE TIME OF THE FOLLOW-UP INVESTIGATION, THE CUSTOMER INDICATED THEY WANTED TO BE TRANSPARENT THAT THE REASON WHY THEY ARE ASKING FOR THE DOCUMENTATION WAS DUE TO PENDING LITIGATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REQUEST. THE CUSTOMER WAS REQUESTING THE SERVICE HISTORY REGARDING THE INVOLVED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2939622 AVALON FM50 FETAL MONITOR AVALON FM50 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 865071 00884838000438

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other