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 08/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device stopped functioning.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device stopped functioning.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be switching on automatically.This fault was attributed to corrosion on the membrane tail.The fault could not be replicated after clearing the corrosion.The device was scrapped by heartsine and the customer was provided with a replacement device.
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Search Alerts/Recalls
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