BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADBAND HB-8 FOR TDH39

    MDR report key: 20652345 · Received November 11, 2024

    Report

    Report Number
    9612197-2024-00006
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 13, 2025
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DEVICE BEING RETURNED, INVESTIGATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540484 HEADBAND HB-8 FOR TDH39 HEADBAND HB-8 FOR TDH39 EWO NATUS MEDICAL DENMARK APS 1-25-12210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown