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 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine has requested return of 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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The distributor contacted heartsine to report that their customer's device would not power on.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as upon return the device could not be powered on.This fault was attributed to the failure of the pogo-pin.Device stored outside of the indicated conditions may have contributed to the pogo-pin failure.The device was scrapped by heartsine and the customer was provided with a replacement device.
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Event Description
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The distributor contacted heartsine to report that their customer's device would not power on.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.
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Search Alerts/Recalls
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