Model Number AED PLUS |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
Necrosis (1971)
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Event Date 03/01/2023 |
Event Type
Death
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Manufacturer Narrative
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Zoll medical corporation has not received the device 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 an 89-year-old female patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe 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 for evaluation and no data files were provided for review.Instead, the customer was contacted and indicated the crew was instructed by the team lead to perform cpr during the device's analyses.Motion artifact from the compressions likely impacted the patient's ecg and influenced the analyses results.The customer will be retraining operators to ensure proper use of the aed plus device for future events.There is no indication of a device malfunction.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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