CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP; AUTOMATED EXTERNAL DEFIBRILATOR
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Model Number G5A-80A |
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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The customer's report was observed during review of the device logs.However, the device was put through extensive testing including full functional testing without duplicating the report.The main board and capacitor were replaced as a precaution.The device was recertified and returned to the customer.The electrode pads used were not returned as part of this investigation.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 functional 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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Search Alerts/Recalls
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