Model Number 1000 |
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 07/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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A customer contacted physio control to report that audio prompts in their device were in incorrect language.The customer may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
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Manufacturer Narrative
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The customer has not agreed to return the device for the investigation.The device was not returned to physio control.The reported issue could not be verified, and root cause could not be determined.H3 other text : not returned to manufacturer.
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Event Description
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A customer contacted physio control to report that audio prompts in their device were in incorrect language.The customer may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
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Search Alerts/Recalls
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