BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON CABLELESS ECG/IUP TRANSDUCER

    MDR report key: 20925901 · Received December 13, 2024

    Report

    Report Number
    9610816-2024-000971
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 27, 2024
    Report Date
    January 10, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON CABLELESS ECG/IUP TRANSDUCER INDICATING THAT A UTERINE RUPTURE OCCURRED DURING ACTIVE LABOR AND THE INTRAUTERINE PRESSURE CATHETER WAS DISPLAYING INADEQUATE CERVICAL CHANGE. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT AND NEW INFORMATION WAS PROVIDED. THE PATIENT WAS NOT DIAGNOSED WITH PLACENTA PREVIA, AND NO BLEEDING WAS PRESENT DURING LABOR ON THIS PATIENT WITH NO PRIOR C-SECTIONS. THE PATIENT RECEIVED A BLOOD TRANSFUSION, THE RUPTURE WAS REPAIRED AND WAS DISCHARGED TO HOME IN STABLE CONDITION. THE OPERATIVE NOTE STATED, 'UTERUS WITH STELLATE RUPTURE ON THE LOWER LEFT SIDE THAT INCORPORATED THE POSTERIOR WALL AND CARRIED AROUND THROUGH THE SIDE WALL AND THE LOWER UTERINE SEGMENT'. THE PRESSURE CATHETER WAS NOT SPECIFICALLY THE CAUSE OF THE RUPTURE, BUT THE CUSTOMER WAS CONCERNED WITH THE ACCURACY OF THE AS A DRIVING FORCE FOR MANIPULATION OF OXYTOCIN DOSING. BASED ON THIS INFORMATION, THE PRESSURE CATHETER WAS NOT THE DIRECT PHYSICAL CAUSE OF THE UTERINE RUPTURE, BUT THE CUSTOMER WAS CONCERNED WITH THE VALUES PROVIDED MAY HAVE DRIVEN OXYTOCIN DOSING, WHICH MAY HAVE BEEN A FACTOR IN THE EVENT; HOWEVER, THE TRUE CAUSE REMAINS UNKNOWN. THROUGH COMMUNICATION WITH THE ACCOUNT MANAGER, IT WAS CONFIRMED THAT THE IUPC CATHETER BEING USED FOR MEASUREMENT WAS A KOALA IUPC, WHICH IS NOT MANUFACTURED BY PHILIPS. THE MANUFACTURER OF THE CATHETER PART ID PRODUCT NUMBER IPC-5000 WAS IDENTIFIED TO BE CLINICAL INNOVATIONS WHICH IS PART OF LABORIE MEDICAL TECHNOLOGIES. THE CUSTOMER INDICATED THEY HAVE BEEN IN CONTACT WITH THEIR KOALA IUPC CATHETER REPRESENTATIVE REGARDING THE ISSUE AS WELL. BASED ON THE INFORMATION AVAILABLE, THE REPORTED PROBLEM WAS RELATED TO THE KOALA IUPC CATHETER AND WAS UNRELATED TO THE PHILIPS TRANSDUCER. NO FURTHER INVESTIGATION BY PHILIPS IS NECESSARY AS THE PRODUCT IS NOT MANUFACTURED BY PHILIPS. LABORIE MEDICAL TECHNOLOGIES HAS BEEN NOTIFIED OF THE ISSUE FOR FURTHER INVESTIGATION. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION BY PHILIPS IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED A UTERINE RUPTURE OCCURRED DURING ACTIVE LABOR AND THE INTRAUTERINE PRESSURE CATHETER WAS DISPLAYING INADEQUATE CERVICAL CHANGE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413710 AVALON CABLELESS ECG/IUP TRANSDUCER AVALON CABLELESS ECG/IUP TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866077

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Death| R