Model Number R SERIES |
Device Problems
Failure to Capture (1081); Pacing Problem (1439); Unable to Obtain Readings (1516); Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/27/2021 |
Event Type
malfunction
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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 pace a patient (age & gender unknown), the device was unable to pace, failed to capture the patient's heart rhythm, and was missing sync markers.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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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference event (device problem code).Evaluation: the device was returned to zoll medical corporation.The customer's report was verified and the onestep pacing cable was replaced to remedy the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that while attempting to pace a patient (age & gender unknown), the device was unable to obtain an ecg signal via one step pacing cable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Search Alerts/Recalls
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