Model Number AED PRO |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/04/2021 |
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 the clinician obtained another device to continue treating the patient.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 returned to zoll united kingdom and performed to specification.The device passed functional stress testing without duplicating the report.The device was recertified and returned to the customer.The clinical data file from the event was reviewed and it was determined that the device worked as designed and within the limitations of the technology available.The log shows that all four events were classified as asystole due to the ecg was below 100 microvolts.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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