CARDIAC SCIENCE CORPORATION G3, AED, AHA 2010, US ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 9300E-1001 |
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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Event Description
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Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via electrode pads.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 data logs.However, the device was put through extensive testing including daily/weekly/monthly testing and full functional testing without duplicating the report.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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