Model Number 350P |
Device Problem
No Audible Prompt/Feedback (2282)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2022 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report that their device was not providing audible prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported 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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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as upon return the device did not issue audio prompts.The reported fault was attributed to damaged speaker cables.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 customer contacted heartsine to report that their device was not providing audible prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported event.
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Search Alerts/Recalls
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