BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS

    MDR report key: 25068688 · Received May 4, 2026

    Report

    Report Number
    3010838917-2026-00002
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 26, 2026
    Manufacturer
    AIRLIFE FINLAND OY
    Product Code
    HGP
    UDI-DI
    10190752142176
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 04 MAY 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE INFORMATION KNOWN AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-14359. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT WAS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FETAL SCALP ELECTRODES ARE DIFFICULT TO DEPLOY DURING INSERTION DUE TO THE SLEEVE BECOMING STUCK, RESULTING IN DEVICE DISCARD AND THE NEED TO USE AN ADDITIONAL ELECTRODE. NO HARM WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148546 VITAL SIGNS FETAL SPIRAL ELECTRODE FOR COROMETRICS HGP AIRLIFE FINLAND OY 7000AAO S27244-H 10190752142176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown