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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 09/27/2023 |
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 27-sep-2023, abbott point of care (apoc) was contacted by a customer who reported that smoke was coming our of battery compartment and from barcode scanner area of i-stat 1 analyzer (b)(6).Customer is not using abbott recommended batteries (currently customer is using 9 volt nippon and uniros batteries).The analyzer will repaired and returned to the customer.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, using batteries with carrier with red fused carrier at the time of the event.Therefore, the analyzer is unlikely to become hot to touch, failing safe.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 11-dec-2023.The customer reported that smoke was emitted from the battery compartment and barcode scanner area of i-stat 1 analyzer s/n (b)(6).Failure analysis confirmed the complaint, and the cause was attributed to the failure of the capacitor c26 on the main pcb.Per the incident summary, customer was using 9 volt nippon and uniros batteries instead of 9-volt lithium batteries (apoc list number: 06f21-26) per art: 714364-00y, of the i-stat system manual which has a safety feature that provides protection preventing the i-stat 1 analyzer from overheating due to component failure within the analyzer circuitry.A rocketware search spanning three months revealed one similar incident.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 43, which is less than the expected 183 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 capacitor in the c26 location.
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Search Alerts/Recalls
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