CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, FRN/INTL ENG; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5A-11A |
Device Problem
High impedance (1291)
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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 without duplicating the report.An internal inspection resulted in no findings.The report was cleared and did not reoccur.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 biomed testing, the device failed for high impedance.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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