HEADBAND HB-8 FOR TDH39

Description of Event or Problem

CUSTOMER HAS PUT ON THE HEADPHONES, THE EARPIECE HAS BROKEN OUT AND THE HEADBAND HAS COME AGAINST THE HEAD (BLOODY HEAD INJURY).

Additional Manufacturer Narrative

CUSTOMER REPORTS BROKEN TDH-39 HEADSET. THEY ALSO REPORT A PATIENT INJURY (MINOR ABRASION). BROKEN HEADSET IS BEING RETURNED TO NATUS TRACKING # (B)(4). 15 NOV: DEFECTIVE HEADSET RECEIVED INTO WAREHOUSE 19 NOV: BROKEN HEADSET BOOKED IN AT CASE (B)(4) FOR RETURN 20 NOV BROKEN HEADBAND RETURNED TO SUPPLIER (B)(4) TRACKING # (B)(4). REPLACEMENT DEVICE SUPPLIED 12 NOV 2024 (B)(4). SCAR- (B)(4) POENED AGAINST SUPPLIER (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.

Description of Event or Problem

CUSTOMER HAS PUT ON THE HEADPHONES, THE EARPIECE HAS BROKEN OUT AND THE HEADBAND HAS COME AGAINST THE HEAD (BLOODY HEAD INJURY).

Additional Manufacturer Narrative

DEVICE BEING RETURNED, INVESTIGATION.