BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 12804832 · Received November 12, 2021

    Report

    Report Number
    9610816-2021-10491
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    November 3, 2021
    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
    CA
    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

    FOLLOWING ALLEGATIONS WERE MADE BY (B)(6): FETAL DEATH, CODE 333, MOVING BABY TO RESUS ROOM, RUPTURED UTERUS FOR MOTHER. PHILIPS DATA ANALYTICS TEAM PROVIDED COMPLAINT SEARCH DATA RESULTS ON THE FOLLOWING PARAMETERS:"TRACKWISE QUERY: CLOSED PRS INCLUDED"; "INITIATE DATE: AFTER 09/01/2016;" "CATALOG ITEM IDENTIFIER: 865071", "SCOPE: COMPLAINTS". DATA SEARCH RESULTED IN TOTAL OF FOUR RECORDS FROM THE OTTAWA HOSPITAL THAT WERE REPORTED TO THE CA ((B)(6)) AND THAT ALLEGED DEATH/SERIOUS INJURY. IN ALL OF THE CASES THERE WAS NO PRODUCT MALFUNCTION OF THE PHILIPS DEVICE. ISSUES WERE EVALUATED BY THE PHILIPS ENGINEERING RESEARCH AND PHILIPS CLINICAL SUPPORT ENGINEERING: DIFFICULTY INTERPRETING READINGS; INSTRUCTING THE CUSTOMER ABOUT THE HEART MEASUREMENT OF THE FETAL MONITOR; THERE WAS NO MALFUNCTION OF THE PHILIPS DEVICE. SN (B)(6). CROSS CHANNEL VERIFICATION (CCV) ASSISTANCE; INSTRUCTING THE CUSTOMER ABOUT CCV FUNCTIONALITY; THE ISSUE WAS NOT CAUSED BY A MALFUNCTION OF THE DEVICE. SN (B)(6). THE CUSTOMER IS REQUESTING CLINICAL SUPPORT REGARDING THE CROSS CHANNEL VERIFICATION (CCV); THIS ISSUE WAS RESOLVED BY INSTRUCTING THE CUSTOMER; NO MALFUNCTION OF THE DEVICE. SN (B)(6). THE CUSTOMER REQUESTED CLINICAL SUPPORT REGARDING THE CROSS CHANNEL VERIFICATION (CCV); THIS ISSUE WAS RESOLVED BY INSTRUCTING THE CUSTOMER; THE ISSUE WAS NOT CAUSED BY A MALFUNCTION OF THE DEVICE. SN (B)(6). FURTHERMORE, MANAGER FOR CLINICAL SPECIALIST HOSPITAL PATIENT MONITORING FOR PHILIPS CANADA STATED THAT THE CUSTOMER HAS BEEN TRAINED ACCORDINGLY ON THE PROPER USE OF THE PHILIPS DEVICES. SEVERAL ATTEMPTS (ON 13-DEC-2021, 16-DEC-2021 AND 21-DEC-2021) WERE MADE BY THE CANADA KEY MARKET TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING REPORTED ISSUES SPECIFICALLY: "FETAL DEATH", "CODE 333", "MOVING BABY TO RESUS ROOM ", "RUPTURED UTERUS FOR MOTHER" BUT NONE WERE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS BEING MOVED TO ANOTHER ROOM AND THE MOTHER SUSTAINED A RUPTURED UTERUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS BEING MOVED TO ANOTHER ROOM AND THE MOTHER SUSTAINED A RUPTURED UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703355 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