Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problems
Death (1802); No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2019 |
Event Type
Death
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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 treat 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.
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Manufacturer Narrative
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This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.This report was inadvertently submitted as a duplicate.The reported event was originally reported under medwatch 1220908-2019-03653.
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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 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.
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Manufacturer Narrative
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The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
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Search Alerts/Recalls
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