BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1053 FREEFIT

    MDR report key: 18649574 · Received February 6, 2024

    Report

    Report Number
    9612197-2024-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 28, 2024
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    ETW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REPORT REF COMPLAINT# (B)(4) CUSTOMER CALLED, THAT THE AURICAL HAD EXPLODED WITH LOTS OF SMOKE AND THE BATTERY LEAKING BLACK DROPLETS. NO ONE WAS HURT, NO DAMAGE TO INTERIOR. PICTURES REQUESTED AND WILL FOLLOW. 30 JAN TS SENT QUESTIONNAIRE TO THE CUSTOMER - AWAITING FEEDBACK. 02 FEB TS FOLLOWED UP WITH THE CUSTOMER - AWAITING FEEDBACK. 06 FEB TS FOLLOWED UP WITH THE CUSTOMER - AWAITING FEEDBACK. 08 FEB - EMAIL WITH PHOTOS RECEIVED - NO QUESTIONNAIRE RECEIVED. PHOTOS SHOWS THE UNIT AND THE SERIAL NUMBER, THE COLLAR ON THE CHARGER. NO PHOTOS OF THE BATTERY USED OR DAMAGE TO THE DEVICE. 15 FEB FIELD SERVICE ARE ONSITE AND CHECK THE DEVICE- ADDITIONAL PHOTOS PROVIDED. CONFIRMATION. THAT THE BATTERY USED IS AN ALKALINE BATTERY. THE ALKALINE BATTERY LEAKED - NOT EXPLODED. THE COLLAR WAS ON THE CHARGING UNIT WHICH GOES AGAINST THE GUIDANCE IN THE IFU- SECTION 5.1 REFERS TO THE USE OF THE ALKALINE BATTERY WITH THE FREEFIT. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT) THE CURRENT RISK FILE (B)(4) REV 06 - 1053 AURICAL FREEFIT - RISK ANALYSIS HAZARD ID 5.32 IDENTIFIES THIS ISSUE HARM - DELAY IN USE OF THE SYSTEM OR TREATMENT. CAUSE- DEVICE NOT FUNCTIONING DUE TO ELECTRICAL COMPONENT FAILURE. SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0).

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF COMPLAINT(B)(4). NO INJURIES OR PATIENT/USER INVOLVEMENT REPORTED DEVICE REQUESTED FOR RETURN

    Description of Event or Problem · 0

    CUSTOMER CALLED, THAT THE AURICAL HAD EXPLODED WITH LOTS OF SMOKE AND THE BATTERY LEAKING BLACK DROPLETS. NO INJURIES REPORTED, NO DAMAGE TO INTERIOR. PICTURES REQUESTED AND WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087282 1053 FREEFIT 1053 FREEFIT ETW NATUS MEDICAL DENMARK APS 8-62-49100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown