BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADBAND HB-7 FOR TDH39

    MDR report key: 20681699 · Received November 14, 2024

    Report

    Report Number
    9612197-2024-00007
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    November 12, 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 HEADPHONE HEADBAND BROKE WHEN THE CUSTOMER PUT IT ON. GOT THE HEADBAND AGAINST HIS HEAD AND IT CAUSED AN INJURY TO HIS HEAD. THREE ATTEMPTS MADE TO HAVE DEVICE RETURNED. SIMILAR FAILURE ON 9612197-2024-00006 INVESTIGATED BY MANUFACTURER. SCAR-000116 OPENED 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. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT): THE CURRENT RISK FILE: (B)(4) AURICAL AUD & MADSEN A450 - RISK ANALYSIS: (B)(4) REV 12 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.

    Additional Manufacturer Narrative · 0

    MINOR CUT/ABRASION RECEIVED BY PATIENT. DEVICE REQUESTED FOR RETURN.

    Description of Event or Problem · 0

    HEADPHONE HEADBAND BROKE WHEN THE CUSTOMER PUT IT ON. GOT THE HEADBAND AGAINST HIS HEAD AND IT CAUSED AN INJURY TO HIS HEAD.

    Description of Event or Problem · 0

    HEADPHONE HEADBAND BROKE WHEN THE CUSTOMER PUT IT ON. GOT THE HEADBAND AGAINST HIS HEAD AND IT CAUSED AN INJURY TO HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349927 HEADBAND HB-7 FOR TDH39 HEADBAND HB-7 FOR TDH39 EWO NATUS MEDICAL DENMARK APS 1-25-12200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown