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

Description of Event or Problem

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

Additional Manufacturer Narrative

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

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

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.