BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1066 MADSEN ASTERA 2 WITH ACP, ISO CAL. INCL. HB-7

    MDR report key: 22225683 · Received June 17, 2025

    Report

    Report Number
    9612197-2025-00001
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 12, 2025
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REF NATUS COMPLAINT # (B)(4). COMPLAINT INVESTIGATION COMPLETED BY TECHNICAL INVESTIGATION GROUP. THIS INVESTIGATION FOUND THAT THE DEVICE SHOWS A WARNING SIGN AND SHUTS DOWN DUE TO OVERLOAD AFTER 2.5 SECONDS. THE FEEDBACK EXPOSURE IN THE TEST SETUP IS NOT CONSIDERED HARMFUL ACCORDING TO THE NIOSH REGULATIONS. FURTHER FEEDBACK BY AUDIOLOGIST CONFIRMED INITIAL FINDINGS OF TECHNICAL INVESTIGATION GROUP AND ADHERENCE TO NIOSH STANDARD. AS PER (B)(4) REV 12 - 1066 MADSEN ASTERA2 - RISK ANALYSIS: HAZARD ID 10.15 CAUSE- (MONITOR VC) EXCESSIVE AUDIO OUTPUT TO USER/OPERATOR DUE TO FLAWS IN SW DESIGN OR SYSTEM CONTROL. EFFECTS/HARM - DELAY IN USE OF THE SYSTEM WITH NO CLINICAL EFFECTS. RESIDUAL RISK 0 (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. RISK LEVEL DEEMED LOW AND ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR COMPLAINT NUMBER (B)(4). AS PER (B)(4). HAZARD ID 10.15 CAUSE- (MONITOR VC) EXCESSIVE AUDIO OUTPUT TO USER/OPERATOR DUE TO FLAWS IN SW DESIGN OR SYSTEM CONTROL. EFFECTS/HARM - DELAY IN USE OF THE SYSTEM WITH NO CLINICAL EFFECTS. RESIDUAL RISK 0 (LOW) AND ACCEPTABLE.

    Description of Event or Problem · 0

    LOUD FEEDBACK THROUGH FREEFIELD SPEAKER CAUSES AUDIOLOGIST EAR PAIN NO INJURY TO USER OR PATIENT.

    Description of Event or Problem · 0

    DEVICE SWITCHED TO THE FREEFIELD SPEAKER WILE THE TALK-FORWARD FUNCTION IS STILL IN USE THE AUDIOLOGIST THAT WAS EXPOSED TO LOUD NOISE RESULTING IN EAR PAIN. NO HARM CAUSED TO USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91816 1066 MADSEN ASTERA 2 WITH ACP, ISO CAL. INCL. HB-7 1066 MADSEN ASTERA 2 EWO NATUS MEDICAL DENMARK APS 8-04-13127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown