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 11/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine has received 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 device may not be providing sufficient voice 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's investigation of the device confirmed the reported fault as upon receipt the device was found to be emitting audio prompts that were barely audible.This fault was attributed to adverse storage of the device.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 device may not be providing sufficient voice 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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