On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer reporting that downloader sn (b)(4) became hot to the touch.The customer stated they smelled what seemed to smell like burnt component coming from the downloader.This prompted the user/operator to touch the downloader, this is when they discovered the downloader was hot to the touch.The customer confirmed they are using the correct cable that came with the downloader.The product was replaced at no charge and returning for investigation along with its cable and power supply.There are no injuries associated with this event.Per i-stat1 system manual: art: 714368-00k, rev.Date: (b)(6) 2012: the downloader/recharger can recharge a rechargeable battery in the analyzer.If the analyzer contains a rechargeable battery, the battery begins recharging automatically as soon as the analyzer is placed in the downloader/recharger.The downloader/recharger also has a compartment for recharging a rechargeable battery outside the analyzer.Placing an analyzer in a downloader/recharger will automatically initiate recharging of the rechargeable battery.The indicator light on top of the downloader/recharger will be green (trickle charge), red (fast charge), or blinking red (fast charge pending) when an analyzer with a rechargeable battery is placed in the downloader/recharger.As well, placing a rechargeable battery into the recharging compartment will automatically initiate trickle recharging.The indicator light near the recharging compartment will be green when a rechargeable battery is placed in the compartment.
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Apoc incident # (b)(4).The investigation was completed on 07/27/2018.The customer reported that there was burnt smell coming from downloader recharger (drc) s/n (b)(4) and it was hot to touch.Drc s/n (b)(4) has not been returned to flex despite multiple requests; therefore, no evaluation could be performed.As of 18-jul-2018, the customer confirmed that they still had (b)(4) at their facility.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
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Apoc incident #: (b)(4).The investigation was completed on 12/05/2018.The customer reported that there was a burnt smell coming from downloader recharger (drc) s/n (b)(4) and it was hot to touch.The customer complaint was not reproduced, but the cause was determined to be defective components d14, d15, and q1 on the main board of the drc, which confirmed that the incident occurred.A deficiency has been identified.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No corrective or preventive action is required at this time.
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