BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 11900494 · Received May 28, 2021

    Report

    Report Number
    1218950-2021-10607
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 18, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    HGP
    UDI-DI
    20884838007431
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. THE COMPLIANT WAS CONFIRMED, UPON RECEIPT OF THE DEVICE THE NEEDLE WAS FOUND TO BE BROKEN APART FROM HE ELECTRODE HUB. THE FAILURE WAS DETERMINED TO BE MOST LIKELY DUE TO USER ERROR THE FAILURE WAS DETERMINED TO BE MOST LIKELY DUE TO USER ERROR. THE CUSTOMER WAS PROVIDED INFORMATION AND THE DEVICE WAS SCRAPPED. NO FURTHER ACTIONS WERE TAKEN AND NONE ARE WARRANTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT FSE WENT MISSING AND WAS FOUND ON THE NEWBORN'S HEAD. THE CUSTOMER ALSO STATED THERE WAS NO ABNORMALITY IN THE NEWBORN PATIENT AFTER REMOVAL OF THE NEEDLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FSE WENT MISSING AND WAS FOUND ON THE NEWBORN'S HEAD. THE CUSTOMER ALSO STATED THERE WAS NO ABNORMALITY IN THE NEWBORN PATIENT AFTER REMOVAL OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796671 FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE HGP PHILIPS NORTH AMERICA LLC 989803137631 192600 20884838007431

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other