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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The device was evaluated by zoll medical germany.The customer's report was duplicated and attributed to a faulty pace/defib engine board.The pace/defib engine board will be replaced to resolve the report.The device will be recertified and returned to the customer once the repair estimate has been completed.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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