Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Patient Involvement (2645)
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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 during biomed testing, the device displayed an "ecg fault 7" message.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical (b)(6) and the customer's report was observed during review of the device activity logs.However, the device was put through extensive testing without duplicating the report.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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