CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5A-80C |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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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 bench handling, power cycling and functional stress testing without duplicating the report.The error was cleared from the logs and did not reoccur.An internal inspection found no discrepancies.The main board was replaced and scrapped 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 displayed an "ecg fault -501" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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