Model Number AED PLUS |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that during functional testing, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.No accessories were returned as part of this investigation.The clinical log is not available for review.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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