Model Number 350P |
Device Problem
Inappropriate Audible Prompt/Feedback (2280)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report that their device was received with the incorrect language configuration.The device should have been configured for us english but was received with uk english.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use reported for this event.
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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 customer contacted heartsine to report that their device was received with the incorrect language configuration.The device should have been configured for us english but was received with uk english.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use reported for this event.
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Manufacturer Narrative
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Mfr report was submitted in error.This report is a duplicate of mfr report # 3004123209-2023-00044.The investigation will continue in mfr report # 3004123209-2023-00044.
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Search Alerts/Recalls
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