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 device for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during functional testing, the device failed to discharge.Complainant did not indicate that there was any 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.The customer's report was observed and attributed to the internal handles.Testing confirmed that the shock button was not functioning.The internal handles were scrapped.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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