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
Data Problem (3196)
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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 received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that during functional testing, the device prompted a "sdram data problem" error message.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 for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including daily/weekly/monthly testing, d/w/m self-test, and stress testing without duplicating the report.The main board was replaced as a precaution.The board was scrapped after testing.An internal inspection found no discrepancies.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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Search Alerts/Recalls
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