The customer reported problem was not confirmed.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was not returned for servicing which not correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4).Which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
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Case #: (b)(4).Case subject: npi error when running pm test on 8300 unit account name: (b)(6).Account #: (b)(6).Asset name: 8300 etco2 module, v8 (b)(6).Patient or user involvement: no.Patient or user harm: no.Case description: tech called in for help on 8300 unit serial # (b)(4).Case resolution: tech get error disposable disconnected when run pm test, try to also run calibrations still get error, tech will send unit in for repair services confirm level one quote for repair.Tech thank me for my assist.
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