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 12/01/2022 |
Event Type
malfunction
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Event Description
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A distributor contacted heartsine to report that a customer¿s device was not able to be powered on.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 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 was not able to be powered on.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.The reported fault was attributed to impact damage from uses error.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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