Model Number X SERIES |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 02/27/2024 |
Event Type
Death
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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 defibrillate a 74-year-old female patient on full advanced life support, the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that the patient subsequently expired.
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Manufacturer Narrative
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The device was not returned to zoll medical corporation, instead the clinical file was received.Review of the clinical file from the reported event concluded that the device worked as designed and within the limitations of the technology.Review of the clinical file identified conditions that qualify as a shockable event such as cpr waveform compressions were continued throughout the analysis period which introduced significant artifact into the ecg.The presence of this artifact obscured the underlying rhythm and shifted the analysis results to a "shock advised" result.This claim has been closed as device meets specification.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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