Model Number R SERIES |
Device Problem
Energy Output Problem (1431)
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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 internally dumped the energy.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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The device was returned to zoll medical germany for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including defib shock testing without duplicating the report.All connection ports were inspected and passed.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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