BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MADSEN ASTERA 2

    MDR report key: 24245277 · Received February 3, 2026

    Report

    Report Number
    9612197-2026-00003
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 13, 2026
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR INTERNAL CASE NUMBER (B)(4). WE WILL BE REQUESTING THE DEVICE TO BE RETURNED. RISK REVIEW: AS PER (B)(4) MADSEN ASTERA2 RISK ANALYSIS. HAZARD ID 6.6 CAUSE- MECHANICAL BREAKAGE, CAUSING SHARP CORNER, EDGES OR PINCH POINTS. E.G. DUE TO STEADY FORCE APPLIED ON THE DEVICE. (HIT BY SOMETHING). EFFECTS/HARM - MINOR PHYSICAL TRAUMA INJURIES. SEVERITY- 3 (NEGLIGIBLE) RESIDUAL RISK 3 (LOW) AND ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    NO SIGNIFICANT HEALTH IMPACT OR CONSEQUENCE HEADBAND HB-8 FOR TDH39 (PART NUMBER 1-25-12210) IS SENT TO THE CUSTOMER. ADDITIONALLY, THE CUSTOMER REFUSED TO RETURN THE DEFECTIVE PART OF THE DEVICE. RISK REVIEW: - AS PER (B)(4) REV 13 - 1066 MADSEN ASTERA2 RISK ANALYSIS HAZARD ID 6.6 CAUSE- MECHANICAL BREAKAGE, CAUSING SHARP CORNER, EDGES OR PINCH POINTS. E.G. DUE TO STEADY FORCE APPLIED ON THE DEVICE. (HIT BY SOMETHING). EFFECTS/HARM - MINOR PHYSICAL TRAUMA INJURIES. SEVERITY- 3 (MARGINAL) RESIDUAL RISK 3 (LOW) AND ACCEPTABLE. THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. THE RESIDUAL RISK IS CONSIDERED LOW AND ACCEPTABLE.

    Description of Event or Problem · 0

    THE USER HAS INFORMED ABOUT BROKEN HEADPHONES. HE STATED THAT THIS HAS HAPPENED TWICE. THE FIRST TIME, CAUSING PAIN TO A PATIENT WHEN PLACING HEADPHONES ON HER HEAD. THE SECOND TIME WAS EARLIER TODAY AND IT BARELY BUMPED THE PATIENT'S HEAD. NO MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE USER HAS INFORMED ABOUT BROKEN HEADPHONES. HE STATED THAT THIS HAS HAPPENED TWICE. THE FIRST TIME, CAUSING PAIN TO A PATIENT WHEN PLACING HEADPHONES ON HER HEAD. THE SECOND TIME WAS EARLIER TODAY AND IT BARELY BUMPED THE PATIENT'S HEAD. NO MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305254 MADSEN ASTERA 2 MADSEN ASTERA 2 EWO NATUS MEDICAL INCORPORATED 1-25-12200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown