HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,HU,350-STR-HU-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 350P |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2022 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report a non-critical issue with their device.Upon evaluation of the customer¿s device, heartsine observed that the device was unable to be powered on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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During evaluation of the device for a non critical issue, the device was unable to be powered on.This fault was attributed to corrosion on the membrane tail.This led to partial short between two tracks, resulting in the returned pad-pak depletion and the device being unable to power on.The corrosion on the membrane tail would suggest that the device had been stored outside the indicated conditions; however, this could not be verified by other means i.E.No corrosion observed on the screws or usb contact collars.The device was scrapped by heartsine and the customer was provided with a replacement device.
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