Model Number 8011-0501-01 |
Device Problem
Grounding Malfunction (1271)
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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 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 during biomed testing, the associated defibrillator failed leakage current test using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The internal handles were returned to zoll medical corporation and the customer's report was not replicated or confirmed.The internal handles were put through extensive testing including full functionality testing multiple discharges and leakage testing without duplicating the report.The internal handles were returned to the customer.No trend is associated with reports of this type.
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Manufacturer Narrative
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After further investigation it was determined that the cause of the problem was due to a test set up configuration and was not due to a malfunction of the device.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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