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 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 defibrillate a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believed 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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Zoll medical canada evaluated the device and the device performed to specification.The customer's report was not observed during evaluation of the device.Review of the file determined the device advised shock as two of the three analyses were shockable as per the zoll algorithm.Review of the clinical file identified multiple conditions that qualify as a shockable event.Cpr was continued throughout all three segments of the analysis.Cpr interference greatly impacts the waveform metrics used to determine shockability.And in this case directly caused the resulting shockable decision.The device worked as expected within the limitations of the technology.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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