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Catalog Number 04P75-01 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/13/2021 |
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 13-may-2021, abbott point of care (apoc) was contacted by a customer who reported observing smoke coming from the battery comparment area of analyzer sn (b)(4).There was no additional information at the time of this report.A green battery carrier is in the i-stat 1 analyzer at the time of the event.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.In this case the customer stated a green (non-fused) battery carrier is in the i-stat 1 analyzer.The customer was advised of the use error in using discontinued product.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 19-jul-2021.The customer reported smoke was emitted from the battery compartment of analyzer s/n (b)(6).The customer also reported they were using a green battery carrier and that the spring from the battery door appeared to have been snapped off.Failure analysis determined the cause of the smoke was the failure of the tantalum capacitor c13 on the main pcb.The cosmetic damage reported by the customer was determined to have been caused by a drop.A rocketware search spanning six months revealed no similar incidents.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 73, which is less than the expected 203 obtained by the reliability calculations.Therefore, no corrective/preventive action is required as the threshold has not been tripped and no product deficiency was found.Rather, this was a malfunction, which was attributed to the failure of the tantalum capacitor in the c13 location.
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Search Alerts/Recalls
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