Model Number X SERIES |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was 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 not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the provided clinical data file determined that the unit did not meet the criteria to advise a shock.The review concluded that the device operated as designed and delivered the correct analysis.Analysis of reports of this type has not identified anincrease in trend.
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Search Alerts/Recalls
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