BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 2893995 · Received December 21, 2012

    Report

    Report Number
    9610816-2012-00500
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K071800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CLINICIANS NEEDED TO PERFORM AN EMERGENCY C-SECTION TO RESUSCITATE THE INFANT AND EVENTUALLY ADMITTED THE BABY INTO NICU DUE TO INACCURATE FHR READINGS WITH A PHILIPS M2705A AVALON FM50 FETAL MONITOR. THE NURSES DID NOT TRUST THE FHR READINGS THEY WERE GETTING FROM THE ULTRASOUND AND THEREFORE THEY SWITCHED TO THE FETAL SCALP ELECTRODE. THE CUSTOMER STILL QUESTIONED THE READINGS AND THEY DECIDED TO VALIDATED WITH AN EXTERNAL U.S. DEVICE. AS THEY SUSPECTED, THE READINGS DID NOT CORRELATE WITH WHAT THEY WERE GETTING FROM THE M2705A SN# (B)(4) AVALON FM50 FETAL MONITOR. THE READINGS FROM THE EXTERNAL U.S. DEVICE INDICATED THE INFANT WAS IN A COMPROMISED SITUATION AND SO THEY DECIDED TO PERFORM A C-SECTION. THE PROVIDED OB TRACE HAS BEEN VIEWED BY (B)(4) ENGINEER AND INVESTIGATION RESULT WAS MALFUNCTION OF THE FETAL MONITOR IS NOT SEEN. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FETAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CLINICIANS NEEDED TO PERFORM AN EMERGENCY C-SECTION TO RESUSCITATE THE INFANT AND EVENTUALLY ADMITTED THE BABY INTO NICU DUE TO INACCURATE FHR READINGS WITH A PHILIPS M2705A AVALON FM50 FETAL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM50 FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2705A

    Patients

    Seq Age Sex Outcome Treatment
    1