Model Number R SERIES |
Device Problem
Grounding Malfunction (1271)
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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 a routine shift check by a clinician, the device failed leakage current 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 returned to zoll medical canada for evaluation and the customer's report was not replicated or confirmed.The device was put through extensive testing including full functionality testing without duplicating the report.The analog board was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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