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 Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant alleged that during subsequent testing, the device was unable to obtain an ecg signal via 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 was 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 device was recertified and returned to the customer.The clinical data and electrode pads were not returned to zoll medical corporation as part of this investigation.No trend is associated with reports of this type.
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Search Alerts/Recalls
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