Model Number R SERIES |
Device Problem
Grounding Malfunction (1271)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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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 failed the earth ground resistance test.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 australia for evaluation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device log does not capture this type of issue.The analog board and sync cable were replaced as a precaution.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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Manufacturer Narrative
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The device was returned to zoll medical australia; the customer's report was observed and the analog board was replaced.The device was recertified and returned to the customer.The analog board was returned to zoll medical united states; the customer's report was duplicated and attributed to the ecg shield bottom side on the analog board.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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