Model Number R SERIES |
Device Problem
High impedance (1291)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Type
malfunction
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Event Description
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Complainant alleged that during biomed testing, the device failed for high impedance.Complainant indicated that there was no patient involvement in the reported 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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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The customer's report was observed during initial testing.Howerver, 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 of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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