Trackwise # (b)(4).Updated section: g4, g7, h2, h6, h10.Analysis of production: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the reported serial/lot number.The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial/lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period aug 2019 through jul 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Device not returned: (4114/67/3221) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
|