CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5A-80C |
Device Problems
High impedance (1291); Unable to Obtain Readings (1516); 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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Event Description
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Complainant alleged that during functional testing, the device failed impedance testing, did not detect electrode pads and the defib output was out of specification.Complainant indicated that there was no patient involvement in the reported 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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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 daily/weekly/monthly testing and stress testing without duplicating the report.An internal inspection resulted in no findings.The main board was 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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Search Alerts/Recalls
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