BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEXX 6.1

    MDR report key: 3766044 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00019
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    January 23, 2009
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS; HOWEVER, IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. AS A RESULT AN UPDATED VERSION OF 6.1.1. OF THE FITTING SOFTWARE HAS BEEN PROVIDED TOGETHER WITH A CUSTOMER LETTER FOR THE ACOUSTICIANS, INFORMING THEM ABOUT THE ERROR ON (B)(6) 2009. THE LOW LIKELIHOOD OF AN OCCURRENCE OF THE PROBLEM IN COMBINATION WITH THE RISK LEVEL DID NOT NECESSITATE FURTHER ACTION. IT WAS DETERMINED AFTER DISCUSSIONS WITH SHI AUDIOLOGY THAT CUSTOMER NOTIFICATION IS NOT REQUIRED SINCE THE ERROR ONLY OCCURS UNDER VERY SPECIFIC CONDITIONS, AND IN THOSE INSTANCES AN AUDIOLOGY FOLLOWING PROPER FITTING PROTOCOLS WOULD DETECT AND REMEDIATE THE PROBLEM THROUGH 2CM3 COUPLER OR PROBE-MICROPHONE MEASUREMENTS. SECTION 6 OF 2003 AAA PROTOCOL REQUIRES THAT THE AUDIOLOGIST MATCH THE ELECTROACOUSTICAL PERFORMANCE OF THE INSTRUMENT TO THE PRESCRIBED 2CM3 COUPLER TARGET VALUES FOR GAIN AND OUTPUT LIMITING, OR PERFORM PROBE-MICROPHONE MEASUREMENTS. EITHER OF THESE METHODS PRECLUDES AN AUDIOLOGIST FROM FITTING AN INSTRUMENT AFFECTED BY THE INCORRECT CLINICAL FIT ALGORITHM. AS OF TODAY ACOUSTICIANS ARE USING LATER VERSIONS OF THE SOFTWARE 6.4 AND HIGHER IN ORDER TO BE ABLE TO FIT HE CURRENT HEARING AIDS ON THE MARKET.

    Description of Event or Problem · 1

    A BUG HAS BEEN DETECTED IN FITTING SOFTWARE CONNEXX 6.1 DURING AN INTERNAL SOFTWARE CHECK. THIS BUG ONLY OCCURS IN A RARE COMBINATION OF SOFTWARE SETTINGS. NORMALLY THE FAILURE WOULD BE DETECTED BY VERIFICATION OF THE TARGETS WITH AN INDEPENDENT MEASUREMENT SYSTEM TO CORRECT THE SETTING IF NECESSARY. AS A RESULT THE LIKELIHOOD OF OCCURRENCE OF THIS FAILURE IS NEARLY ZERO. POTENTIAL IMPACT: THE INCORRECT AUDIOGRAM TRANSFORMATION WOULD CAUSE A HIGHER GAIN THAN DESIRED TO COMPENSATE FOR THE INDIVIDUAL HEARING LOSS. THIS ERROR MAINLY IMPACTS LOW FREQUENCIES AND EXCEEDS UP TO 19BD ONLY. IT WAS DETERMINED AFTER DISCUSSIONS WITH SHI AUDIOLOGY THAT CUSTOMER NOTIFICATION IS NOT REQUIRED SINCE THE ERROR ONLY OCCURS UNDER VERY SPECIFIC CONDITIONS, AND IN THOSE INSTANCES AN AUDIOLOGIST FOLLOWING PROPER FITTING PROTOCOLS WOULD DETECT AND REMEDIATE THE PROBLEM THROUGH 2CM3 COUPLER OR PROBE-MICROPHONE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666988 CONNEXX 6.1 FITTING SOFTWARE, HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA