BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRCAL 200, 1079

    MDR report key: 8953776 · Received September 2, 2019

    Report

    Report Number
    9612197-2019-00009
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Report Date
    October 1, 2019
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    KHH
    PMA / PMN Number
    K931608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DECLINED TO RETURN THE DEVICE FOR INVESTIGATION, NO DEVICE ANALYSIS RESULTS AVAILABLE. NO SIMILAR COMPLAINTS RECEIVED FOR THE AIRCAL 200, 1079. THIS WILL BE CONTINUED TO BE MONITORED FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY FLASHED AND TURNED OFF AND THERE IS A BURNING SMELL WHEN TURNED ON. THIS DEVICE IS NO LONGER FOR SALE AS WELL AS SERVICE PARTS ARE NO LONGER AVAILABLE. ISOLATED COMPLAINT. INVESTIGATION WAS NOT POSSIBLE AS THE COMPLAINANT WAS ASKED IF IT WAS POSSIBLE TO RETURN THE CONCERNED PRODUCT FOR INVESTIGATION, TO WHICH THE COMPLAINANT RESPONDED IT WAS 'NOT POSSIBLE'. THE UNIT IS NO LONGER IN SERVICE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INVOLVEMENT. RELEVANT TESTS / LABORATORY DATA - THIS IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. LOT # - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. UDI - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. EXPIRATION DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. 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. MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS 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

    AIRCAL 200, 1079 SMELLS LIKE SOMETHING IS BURNING WHEN TURNED ON. DISPLAY FLASHED AND TURNED OFF AND THERE IS A BURNING SMELL WHEN TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746928 AIRCAL 200, 1079 AIRCAL 200, 1079 KHH NATUS MEDICAL DENMARK (GN OTOMETRICS) 8040015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other