Model Number X SERIES |
Device Problem
Failure of Device to Self-Test (2937)
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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 has not received the product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during biomed testing, the device failed self test.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was evaluated by a zoll-approved service provider.The customer's report was duplicated and attributed to the processor/bridge/pace board.The processor/bridge/pace 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 the reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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