On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer (b)(4) would not turn on.Customer reports that the batteries were changed with no improvement.The analyzer, batteries and carrier were hot to the touch when the batteries were taken out.There was no additional information at the time of this report.The product 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.
|
Apoc incident # (b)(4).The investigation was completed on 09/18/2019.Analyzer s/n 374463 was returned because it would not activate and was hot to touch.Failure analysis determined that the cause of the problem was the failure of a 100 ¿f tantalum capacitor (apoc p/n: 013827-01 01) c4 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.
|