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 Date 05/09/2023 |
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 while attempting to treat a 56-year-old male patient, the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The clinical log was not saved and overwritten by testing post event.The device was used off label and not as intended.The device was recertifed successfully and returned to the customer.The operator's guide states that the device must be used on a patient who is unconscious, not breathing and have no pulse.However, the device was applied to a conscious/ coherent patient during the reported event.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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