BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAL 200, 1079

    MDR report key: 25200919 · Received May 18, 2026

    Report

    Report Number
    9612197-2026-00008
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 18, 2026
    Manufacturer
    NATUS SENSORY IRELAND
    Product Code
    KHH
    UDI-DI
    05713315009235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL COMPLAINT FOR CASE (B)(4). MORE INFORMATION REQUESTED FROM COMPLAINANT. DEVICE REQUESTED FOR RETURN FOR FURTHER EVALUATION. RISK RATINGS: THE CURRENT RISK FILE (B)(4), ICS AIRCAL RISK ANALYSIS DOCUMENT WAS REVIEWED. HAZARD I.D 4.6 IDENTIFIES "INADEQUATE STRAIN RELIEF LEADS TO EXPOSED VOLTAGE SOURCE.CONTACTS ON CABLE BECOME DISCONNECTED FROM HEAD. E.G. FOOT SWITCH CABLE, IRRIGATOR CABLE, WATER OR AIR TUBES, ETC. RESIDUAL RISK: MINOR (3). RISK/BENEFIT ANALYSIS: MEDIUM.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE AIRCAL 200 DEVICE. THE USER HAS REPORTED FOR "MINOR ELECTRIC SHOCK" AND "SPARK" .IT WAS REPORTED THAT DURING AN EXAMINATION, THE DEVICE INITIALLY FUNCTIONED NORMALLY. HOWEVER, WHEN REPEATING THE COLD TEST, THE MEMBER OF STAFF RECEIVED A MINOR ELECTRIC SHOCK ACCOMPANIED BY SPARKS FROM THE HANDPIECE. NO MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384059 AIRCAL 200, 1079 AIRCAL 200, 1079 KHH NATUS SENSORY IRELAND 8-04-13300 05713315009235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown