Catalog Number 03P75-06 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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Event Description
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On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported visible smoke coming from i-stat1 analyzer sn (b)(4) during a power up event there was no additional information at the time of this report.The analyzer was replaced at no charge and returning for investigation.Apoc has determined that a component failure within the analyzer circuitry, may lead to the batteries becoming uncomfortably hot to touch in the area of the battery compartment when using a green non-fused battery carrier.However, the customer states that rechargeable batteries were being used at the time of the event.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
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Manufacturer Narrative
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Apoc incident # (b)(4).The investigation was completed on 10/07/2019.Analyzer s/n (b)(4) was returned because it emitted smoke and a burnt smell was noted.Failure analysis determined that the cause of the problem was the failure of a 100 f tantalum capacitor (apoc p/n: 013827-01 01) c26 on the main board of the analyzer, between the primary battery and ground.The capacitor had failed such that it created a short circuit between the battery and ground; current flowing through the shorted capacitor caused heat damage, which gave the capacitor a burned appearance.
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Manufacturer Narrative
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Apoc incident # (b)(4).The investigation was completed on 07/17/2019.The customer reported that smoke was coming out of the battery compartment of analyzer s/n 381359 when the battery was removed, and a burning smell was noted.The customer reported that no one was injured by the incident.Failure analysis could not be performed as analyzer s/n 381359 has not been returned to flex.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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Search Alerts/Recalls
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