CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP; AUTOMATED EXTERNAL DEFIBRILLATOR
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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 data logs.However, the device was put through extensive testing including full functional testing, and stress testing without duplicating the report.An internal inspection found no discrepancies.The error was cleared and did not reoccur.The main board and capacitors were 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 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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