HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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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 12/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine continues to investigate the reported issue and will submit a supplemental report on this event to the fda.
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Event Description
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The customer contacted heartsine to report that the 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 use associated with the reported event.
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Manufacturer Narrative
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The device was not returned to heartsine for evaluation.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted heartsine to report that the 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 use associated with the reported event.
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Search Alerts/Recalls
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