BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 3940905 · Received July 8, 2014

    Report

    Report Number
    9610816-2014-00185
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 19, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PER THAT, THEY STARTED MONITORING THE FETAL HEART RATE (FHR) OF A SINGLE FETUS EXTERNALLY, USING AN ULTRASOUND TRANSDUCER. THE STAFF OBSERVED SOME DECELERATION AND CHANGED TO MONITORING A SINGLE FETAL HEART RATE VIA DIRECT ECG (DECG), USING A SPIRAL FETAL ELECTRODE WITHOUT DISCONNECTING THE ULTRASOUND TRANSDUCER. THE STAFF CONTINUED MONITORING WITH BOTH OPTIONS CONNECTED. THE DECG FHR APPEARED TO INCREASE BUT THIS WAS DUE TO THE TACE SEPARATING FHR BY AN OFFSET OF +20 BPM. THE STAFF THOUGHT THE DECELERATION HAD REVERTED, WHEN IN FACT IT WAS STILL A PROBLEM - THE +20BPM SCALE WAS NOTED BY PRACTITIONERS APPROXIMATELY 25 MINUTES FOLLOWING THE COMMENCEMENT OF DECG MONITORING. THE FHR WAS THOUGHT TO BE IN THE RANGE OF 110BPM, WHEN IT WAS ACTUALLY AROUND 90BPM. THE BABY HAS HYPOXIC ISCHEMIC ENCEPHALOPATHY - CUSTOMER BELIEVES TO BE AT GRADE 3 - 4. THE CUSTOMER STATES THAT THE PRACTITIONERS DID NOT NOTICE THAT THE INCREASE IN FHR WAS RELATED TO THE #20 BPM SCALE, THEY DID NOT REALIZE THE +20 BPM SCALE WAS THE REASON FOR THE APPARENT INCREASE IN FHR. IT IS BELIEVED THAT TRACE SEPARATION WAS ON BUT THIS HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398443 AVALON FM30 FETAL MONITOR SYSTEM, MONITORING, PERINATAL HGM PHILIPS MEDICAL SYSTEMS M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown