Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/27/2021 |
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 pace a patient (age & gender unknown), the device was unable to detect the attached electrode pads.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 and pads were evaluated by zoll medical united kingdom.The customer's report was not replicated or confirmed.The returned pads passed ecg and shock testing without duplicating the report.When using the returned pads, the device was able to recognize the pads and detect and ecg signal without issue.The returned onestep cable was inspected with no discrepancies found.The device data was not available for review as it had been overwritten.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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