Model Number X SERIES |
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 Type
malfunction
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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 a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that there was no 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 data file showed there were seven analyses from the event.Analyses 2-7 were not shockable as the average heart rate was below the 150bpm threshold.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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