Model Number R SERIES |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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's defib output was out of specification.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 not received the product for evaluation and this complaint is still under investigation.
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Manufacturer Narrative
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Zoll medical germany evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs did not show any activity for the reported event.No trend is associated with reports of this type.
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Search Alerts/Recalls
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