BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADBAND HB-7 FOR TDH39

    MDR report key: 16362880 · Received February 13, 2023

    Report

    Report Number
    9612197-2023-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 30, 2023
    Report Date
    June 14, 2023
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    EWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REFERENCE TO COMPLAINT #(B)(4). NO PATIENT INJURY RECORDED, DEVICE MALFUNCTION WITH THE POTENTIAL TO CAUSE INJURY. FAILURE MODE PREVIOUSLY INVESTIGATED RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT): THE CURRENT RISK FILE 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS - DOC-(B)(4) REV 06 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). DEVICE REQUESTED FOR RETURN, INVESTIGATION ONGOING

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REFERENCE TO (B)(4). EVENT SUMMARY (PRODUCT AND PATIENT/USER/ENVIRONMENT EFFECT): 23 FEB 2023: QUESTIONNAIRE RECEIVED. FOLLOW UP WITH CUSTOMER ON SN OF HEADBAND AND RETURN OF DEVICE- AWAITING RESPONSE. 17 APR 2023: FOLLOW UP WITH CUSTOMER ON SN OF HEADBAND AND RETURN OF DEVICE- AWAITING RESPONSE. 11 MAY 2023: FOLLOW UP WITH CUSTOMER ON SN OF HEADBAND AND RETURN OF DEVICE- AWAITING RESPONSE. NO RESPONSE RECEIVED FROM THE CUSTOMER - CASE HAS BEEN CLOSED BY TECHNICAL SERVICE. SHOULD THE CUSTOMER RETURN THE DEVICE THE CASE WILL BE REOPENED FOR FURTHER INVESTIGATION. UDI NOT APPLICABLE. CAPA005378 PREVIOUSLY OPENED TO IN RELATION TO FAILURE MODE; ROOT CAUSE COULD BE ATTRIBUTED TO WILFAN HAVE NOT SET FORTH A SPECIFICATION THEY (CONTRACT MANUFACTURER) NEED TO ADHERE TO AND MIGHT BE USING DIFFERENT MANUFACTURERS/SUPPLIERS FOR THESE ITEMS DEPENDING ON THE LOTS. INTERNAL SCAR AT WILFAN HAS BEEN RE-OPEN WITH WILFAN'S CONTRACT MANUFACTURER, REQUESTING THE SUPPLIER PROVIDES TECHNICAL GUIDANCE ON THE QUALITY ISSUES.

    Description of Event or Problem · 0

    COMPLAINT REGARDING TDH HEADBAND FAILURE - PART 1-25-12200 - HEADBAND HB-7 FOR TDH39. THE STEEL BAR CONNECTING THE HEAD BAND TO THE EAR CUP IS SPRINGING OUT OF THE TOP PLASTIC GROOVE IN THE HEADBAND. IT'S COMES OUT WITH FORCE AND IT HAS HIT A PATIENT ON THE HEAD. NO INJURY REPORTED.

    Description of Event or Problem · 0

    COMPLAINT REGARDING TDH HEADBAND FAILURE - PART 1-25-12200 - HEADBAND HB-7 FOR TDH39; THE STEEL BAR CONNECTING THE HEAD BAND TO THE EAR CUP IS SPRINGING OUT OF THE TOP PLASTIC GROOVE IN THE HEADBAND. IT'S COMES OUT WITH FORCE AND IT HAS HIT A PATIENT ON THE HEAD. MINOR ABRASION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809351 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 Prefer Not To Disclose Other