Model Number 8011-0501-01 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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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 product 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 associated defibrillator failed to discharge using these attached 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 for evaluation.During testing of the internal handles with a simulator, the device did not shock when the shock button on the internal handle was pressed.The malfunction was duplicated and attributed to a faulty discharge button on the paddle.The internal handles were scrapped.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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