HEADBAND HB-7 FOR TDH39

Additional Manufacturer Narrative

NO SIGNIFICANT HEALTH IMPACT OR CONSEQUENCE. DEVICE REPLACED FOR CUSTOMER. (B)(4) OPENED AGAINST SUPPLIER (B)(4). DEVICE INVESTIGATED BY (B)(4). (B)(4) WERE MADE AWARE OF THE ISSUES REPORTED WITH THIS LOT AND OTHER LOTS FROM 2020-2023. BECAUSE OF REPORTED ISSUES, THEY STOPPED PRODUCTION OF THE HEADSETS IN 2023 TO PREVENT ANY FURTHER POSSIBLE BREAKAGES AND COMPLETELY STOPPED SELLING ALL OLDER LOTS FROM 2023 AND EARLIER. THEY HAVE SPENT THE PAST ONE AND HALF YEARS WORKING WITH SUPPLIERS TO MAKE CHANGES TO THE DESIGN AND MATERIALS OF THE HEADSETS TO MAKE THEM STRONGER. THEY HAVE PERFORMED MULTIPLE TESTS ON STRENGTH AND DURABILITY OF THE YOKES AND PLASTIC HOUSING. AS OF Q4 2024 THEY STARTED SELLING THE REVISED HEADSETS AND CONTINUE TO MONITOR AND TEST THE NEWEST INCOMING PRODUCT TO ENSURE THEIR SUPPLIER IS MEETING THEIR REQUIREMENTS. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT): THE CURRENT RISK FILE 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS - (B)(4) HAZARD ID 6.5 IDENTIFIES THIS ISSUE HARM - MINOR INJURY TO THE PATIENT OR USER OR DISCOMFORT. CAUSE- MECHANICAL BREAKAGE, CAUSING SHARP CORNER, EDGES OR PINCH POINTS. E.G. DUE TO STEADY FORCE APPLIED ON THE DEVICE. SEVERITY- MARGINAL (3). RISK LEVEL- MINOR (3). 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

WHEN THE HEADPHONES WERE PUT DOWN, THE METAL SPEAKER ATTACHMENT DETACHED FROM THE PLASTIC FRAME OF THE HEADBAND, WHICH THEN GRAZED THE CUSTOMER'S LOWER LEFT EYE AREA WITH THE RESTORING FORCE OF THE HEADBAND SPRING AND INJURED HIM THERE. THE CUSTOMER BLED AT THE SITE BUT REFUSED FIRST AID MEASURES SUCH AS DISINFECTION OR PLASTERS.

Additional Manufacturer Narrative

MINOR CUT/ABRASION RECEIVED BY PATIENT DEVICE REQUESTED FOR RETURN. AS PER (B)(4) REV 12 - 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS: HAZARD ID 6.5 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. RESIDUAL RISK 3 (LOW) AND ACCEPTABLE.

Description of Event or Problem

WHEN CUSTOMER TOOK TDH-39 HEADPHONES OFF, THE PLASTIC HOLDER BROKE AND THE HEADBAND SEPARATED. HEADPHONES HIT PATIENT'S FACE. THERE ALREADY WAS A CRACK ON THE HEADPHONE HOLDER. CUSTOMER COULDN'T TELL IF CRACK WAS ALREADY THERE WHEN TDH-39 WAS DELIVERED OR APPEARED AFTER TIME. PATIENT WAS SLIGHTLY WOUNDED WITH A SMALL BLOODY WOUND.