Model Number R SERIES |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/29/2023 |
Event Type
malfunction
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown) in ventricular tachycardia, 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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Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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Manufacturer Narrative
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The device was returned to zoll medical canada for evaluation and the device performed to specification.No clinical file was available for evaluation to properly assess the ecg signal as the activity log is not designed to record ecg.The activity log shows the user was not in pad view when attempting to analyze the ecg.The unit will prompt select pads in order to alert the user to switch to pads view using the lead button as the device cannot analyze in lead view.However, the user does not switch to pads view to analyze.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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