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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Event Description
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Complainant alleged that during biomed testing, the device prompted "no shock advise" for a simulated shockable rhythm.Complainant indicated that there was no patient involvement in the reported 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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Manufacturer Narrative
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The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.Review of the device log show no indication of device malfunction.The device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.The pads and battery used during the event were not returned as part of this investigation.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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