Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Death (1802)
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Event Date 09/04/2019 |
Event Type
Death
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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 monitor 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 the patient subsequently expired.
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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 including bench handling and full ecg functionality testing without duplicating the report.The device was recertified and returned to the customer.The electrode pads and multi-function cable used were not returned as part of this investigation.The clinical data was not available.Review of the device activity logs showed no errors related to the customer's report.No trend is associated with reports of this type.
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Search Alerts/Recalls
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