Model Number 8011-0501-01 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation evaluated the internal handles and the customer's report was not replicated or confirmed.The internal handles was put through extensive testing using known good spoons and connected to a test r series, without duplicating the report.The handles passed the continuity testing from the three-month check-out procedure in the internal handles operator's guide.The internal handles were scrapped as a precaution.A replacement set was sent to the customer.No trend is associated with reports of this type.
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Event Description
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Complainant alleged that during biomed testing, the associated device failed to discharge using these attached internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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