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Model Number G5S-01A |
Device Problem
Use of Device Problem (1670)
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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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The device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including full functional testing and defib shock testing without duplicating the report.An internal inspection found no discrepancies.The main board was replaced as a precaution.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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Event Description
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Complainant alleged that during a functional testing, the device displayed a red "x" indicator.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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