BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARTR EP 200

    MDR report key: 10333415 · Received July 28, 2020

    Report

    Report Number
    9612197-2020-00009
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 23, 2020
    Report Date
    July 23, 2020
    Manufacturer
    GN OTOMETRICS (NATUS DENMARK)
    Product Code
    GWJ
    PMA / PMN Number
    K143670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 21 AUG 2020 (REF COMPLAINT# (B)(4)) THIS INCIDENT IS NOW CONSIDERED TO BE NON- REPORTABLE. THIS INCIDENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY OR DEATH. THE INCIDENT OCCURRED DURING DEVICE TESTING BEFORE USING IT. THE SOUND LEVELS MENTIONED IN THE COMPLAINT ONLY POSE A HAZARD FOR CONTINUOUS EXPOSURE TIMES > 15 MINUTES, WHICH IS MUCH GREATER THAN THE PRESENTATION LEVELS USED IN THE AUDITORY BRAINSTEM RESPONSE (ABR) TEST. THE 100 DB LEVEL IS NOT A HAZARD IN SHORT EXPOSURE DURATIONS. THE COMPLAINT REPORTER DID NOT PROVIDE ANY OBJECTIVE MEASUREMENT OF THE OUTPUT, ONLY A QUALITATIVE DESCRIPTION. THE CHARTR EP 200 IS DESIGNED TO LIMIT AUDIO LEVELS TO SAFE LEVELS PER THE IEC 60601-1-40 STANDARD, RELATED HAZARD ID'S 7.1, 7.2, 7.4, HAVE CONTROL MEASURES FOR THIS PURPOSE. BASED ON THE COMPLAINT INFORMATION INDICATING THAT THE IMPEDANCE IS INCORRECT WHEN NOT CONNECTED, IT APPEARS THAT THE PRE-AMP MAY BE DEFECTIVE. THERE IS AN IMPEDANCE TEST THAT SHOULD BE DONE USING THE SYSTEM SOFTWARE. A RISK REVIEW IS NOT REQUIRED AS 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. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. DEVICE HISTORY WAS REVIEWED AND THE PRODUCT PASSED ALL TESTS ACCORDING TO THE CONTRACTED MANUFACTURER. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND.

    Description of Event or Problem · 0

    THE EVENT OCCURRED AS THE DEVICE WAS TESTED, IT WAS VERY / TOO LOUD (20 DB ABOVE) AND IMPEDANCE WAS VERY LOW . NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS TESTED, IT WAS VERY / TOO LOUD (20 DB ABOVE) AND IMPEDANCE WAS VERY LOW, NO PATIENT INVOLVEMENT AS THIS WAS DURING TESTING BEFORE USING THE PART. THE DEVICE WILL BE RETURNED FOR EVALUATION. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. A RISK REVIEW IS NOT REQUIRED AS 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. DEVICE HISTORY RECORD REVIEWED AND PRODUCT PASSED ALL TESTS ACCORDING TO THE CONTRACTED MANUFACTURER.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AS THE DEVICE WAS TESTED, IT WAS VERY / TOO LOUD (20 DB ABOVE) AND IMPEDANCE WAS VERY LOW. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794921 CHARTR EP 200 CHARTR EP 200 GWJ GN OTOMETRICS (NATUS DENMARK) 8-04-12704/1

    Patients

    Seq Age Sex Outcome Treatment
    1