Model Number MSERIES BI-PHASIC |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Information (3190)
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Event Date 11/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Complainant indicated that subsequent testing did not duplicate the reported malfunction.
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Manufacturer Narrative
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The device and electrode pads were returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The electrodes passed testing with no discrepancies found that would contribute to the customer's report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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