Summary of elevated complaint investigation (ecinv) (b)(4)-ecinv for mdr 3005248192-2015-00016 follow-up report 1: investigation into this complaint included an existing data review, quality data review, a product labeling review, a product evaluation, a complaint history review, and a service history review to determine a product deficiency decision.Existing data review: photos were unable to be obtained from this remote site.Information within (b)(4) was reviewed.Supporting information provided by the field service engineer (fse) was documented and analyzed.The pca microcontroller (pn 8-200739-01) connector (j11) had minimal discoloration compared to the mating connector on the lamp-gemini board cable with connector (pn 50-148387).The fse confirmed that the pca microcontroller (pn 8-200739-01) was not replaced.The abbott m2000rt operations manual (pn 200680-107-november 2014) review shows sufficient information exists for the customer troubleshoot error code 4448.The abbo m2000rt service manual (pn 201000-105 - october 2011) review concludes sufficient instructions exist for the fse to troubleshoot error code 4448.Isa 610-028 m2000rt lamp troubleshooting and replacement procedures review concludes sufficient instructions exist for the fse to troubleshoot error code 4448.Quality data review: a service history review was performed for m2000rt instrument system, ln 09k15-01 (sn (b)(4)) indicating a successful installation of the m2000rt instrument system and only this instance of the lamp - gemini board cable with connector (pn 50-148387) needing to be replaced due to discoloration/browning/burning of the lamp cable connector.Product/system/instrument evaluation: the lamp-gemini board cable with connector (pn 50-148387) was not available for return and photographs were not available for review.The description in the complaint ticket indicates the lamp-gemini board cable with connector (pn 50-148387) appeared to be burned at the point of connection to the pca microcontroller.The lamp-gemini board cable with connector (pn 50-148387) plugs into the pca microcontroller (pn 8-200739-01) at connector j11.Additional supporting information was provided by the fse indicating the pca microcontroller (pn 8-200739-01) connector (j11) had minimal discoloration compared to the mating connector on the lamp-gemini board cable with connector (pn 50-148387).If fire had occurred, both the pca microcontroller connector j11 and the mating connector on the lamp-gemini board cable with connector (pn 50-148387) would likely have been equally damaged.The pca microcontroller (pn 8-200739-01) did not require replacement because it was not damaged indicating fire was improbable.Based on the description in the complaint ticket, and additional supporting information provided by the fse via email, this is likely discoloration due to prolonged localized heating of the lamp-gemini board cable with connector (pn 50-148387) which is a known issue addressed by isa 610-028 m2000rt lamp troubleshooting and replacement procedures.The m2000rt instrument system (ln 9k15-01) meets required safety certifications.The lamp - gemini board cable with connector (50-148387) is contained inside a metal enclosure per required safety standards.If fire did occur, it would have been contained within the instrument.The instrument functioned as designed and failed safe.Complaint history review: complaint history review showed that, over the last 2 years, the elevated (b)(4) and one additional complaint were related to the issue of any pre flags set as a result of smoke, discoloration, or fire occurring on the m2000rt instrument system (09k15-01).(b)(4).Isa 610-028 m2000rt lamp troubleshooting and replacement procedures instructs the fse to replace the lamp - gemini board cable with connector if browning or discoloration of the connector is observed.Regular replacement of the lamp - gemini board cable with connector is expected.(b)(4).Product deficiency decision: the instrument meets required safety certifications.The issue was contained within the metal enclosure and failed safe.Based on the results of the investigation, a product deficiency was not identified.
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