BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 1921920 · Received December 6, 2010

    Report

    Report Number
    9610816-2010-00780
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 23, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PT DELIVERED A BABY WITH A LOW APGAR SCORE AND DURING MONITORING BEFORE THE BIRTH, THE FETAL HEART RATE (FHR) WAS DIFFERENT FROM THE AUDIBLE HEART RATE OR THE HEART RATE WAS NOT AUDIBLE ON THE MONITOR. BASED ON THE AVAILABLE INFO, THE PT WAS BEING ASSESSED BY AN OB WHO FOUND THE FETUS TO BE TACHYCARDIA ABOVE 200. PHILIPS IS REPORTING THIS EVENT BECAUSE, A BABY, MONITORED BY A PHILIPS MONITOR, WAS BORN WITH A LOW APGAR SCORE. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT DELIVERED A BABY WITH A LOW APGAR SCORE AND THE TRACE AND AUDIBLE FETAL HEART RATE DID NOT MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM30 FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR