HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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Model Number 350P |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report that their device had intermittent voice prompts.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the 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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Search Alerts/Recalls
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