Model Number X 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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Manufacturer Narrative
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Zoll medical corporation has not received the device 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'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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The device was returned to zoll medical corporation; the customer's report was duplicated and the ecg board was replaced to resolve the report.The board was scrapped after testing.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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