BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MADSEN ACCUSSCREEN 1077

    MDR report key: 9451493 · Received December 11, 2019

    Report

    Report Number
    9612197-2019-00021
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    March 17, 2020
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    GWJ
    PMA / PMN Number
    K122067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT UNIT HAS BEEN RETURNED TO THE SERVICE DEPARTMENT. BATTERY AND MAINBOARD FOUND DEFECTIVE. ACCUSCREEN WITH DEFECT MAINBOARD HAS BEEN REPLACED WITH NEW ATO UNIT. BATTERY WAS DEFECT / BURNED AND HAS BEEN REPLACED WITH A NEW BATTERY. ACCUSCREEN AND PROBE HAS BEEN CALIBRATED,SAFETY,FUNCTION AND FINAL TESTED SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    UPDATE (B)(6)2020 PRODUCT HAS BEEN RETURNED. A CAPA REVIEW HAS BEEN CONDUCTED. THERE ARE NO CAPAS RELATED TO THIS ISSUE. RISK DOCUMENTATION HAS BEEN REVIEWED. FIRE / EXPLOSION HAZARDS RELATED TO BATTERY FAILURE ARE ADDRESSED IN THE RISK DOCUMENTATION. THE ROOT CAUSE FOR THIS FAILURE MODE HAS NOT YET BEEN ESTABLISHED. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    UPDATE 17TH JANUARY 2020 PRODUCT HAS BEEN RETURNED AND INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    BATTERY SEEMS TO HAVE BEEN ON FIRE OR PUNCTURED. THIS HAS DAMAGED THE BATTERY LID.

    Description of Event or Problem · 0

    BATTERY SEEMS TO HAVE BEEN ON FIRE OR PUNCTURED. THIS HAS DAMAGED THE BATTERY LID.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT - DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED. RELEVANT TESTS / LABORATORY DATA - THIS IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE. EXPIRATION DATE / UDI # MISSING. IF IMPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS IS NOT APPLICABLE TO MEDICAL DEVICES. DEVICE MANUFACTURE DATE - UNKNOWN. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

    Description of Event or Problem · 1

    BATTERY SEEMS TO HAVE BEEN ON FIRE OR PUNCTURED. THIS HAS DAMAGED THE BATTERY LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247338 MADSEN ACCUSSCREEN 1077 MADSEN ACCUSSCREEN 1077 GWJ NATUS MEDICAL DENMARK (GN OTOMETRICS) 8-04-13906

    Patients

    Seq Age Sex Outcome Treatment
    1