CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,AUTO,DUT-INTL ENG,CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5A-15C |
Device Problem
Unable to Obtain Readings (1516)
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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 displayed an "ecg fault -501" 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 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.An internal inspection found no discrepancies.The error was cleared from the logs and did not reoccur.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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