Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2019 |
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 monitor a patient (age & gender unknown), the device was unable to obtain an ecg signal.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Complainant indicated that the clinician obtained another device to continue treating the patient.
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Manufacturer Narrative
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The customer's report was observed during review of the device's history log.The device was put through extensive testing without duplicating a malfunction.The analog board was replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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