BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM20 FETAL MONITOR

    MDR report key: 6197914 · Received December 22, 2016

    Report

    Report Number
    9610816-2016-00332
    Event Type
    Death
    Date Received
    December 22, 2016
    Report Date
    November 29, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED. UNFORTUNATELY, THE CUSTOMER PROVIDED INSUFFICIENT INFORMATION (FOR EXAMPLE THE TRACE AND THE SN# OF THE DEVICE ARE NOT AVAILABLE FOR INVESTIGATION) AND DID NOT PROVIDE THE REQUESTED INFORMATION. FOR CLEAR PROBLEM EVALUATION, THE TRACE WOULD HAVE BEEN NEEDED. THE TOCO MP TRANSDUCER COULD NOT CONFIRM THE PROBLEM WITH THE TEST OF ATOM MEDICAL. WHAT EXACT WAS TESTED IS NOT KNOWN. IT REMAINS UNKNOWN HOW THE PROBLEM WAS SOLVED SINCE THE CUSTOMER HAS REFUSED TO PROVIDE FURTHER INFORMATION. THUS THIS CASE HAS INSUFFICIENT INFORMATION FOR A CLEAR CONCLUSION. ATOM MEDICAL HAS TESTED THE DEVICE AND WAS NOT ABLE TO FIND ANY TROUBLE WITH THE DEVICE. THE DEVICE REMAINS AT THE CUSTOMER SITE. IN ADDITION PLEASE NOTE, THE CUSTOMER DID NOT ALLEGE THAT THE DEVICE WAS A FACTOR. INVESTIGATION OF THIS COMPLAINT SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING OR MATERIALS PROBLEM, SUPPORTING THAT ANY FURTHER INVESTIGATION OR CORRECTIVE OR PREVENTIVE ACTION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IN THIS CASE THE CUSTOMER REPORTED A PATIENT INCIDENT WITH A DECEASED FETUS WHERE IT IS NOW IN QUESTION IF THE CUSTOMER MIGHT HAVE MISTOOK THE MATERNAL HEART RATE AS A FETAL HEART RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850896 AVALON FM20 FETAL MONITOR FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2702A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death