CARDIAC SCIENCE CORPORATION G3 PLUS AUTO, AED, AHA 2010, US ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 9390A-1001 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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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 was unable to obtain an ecg signal via pads.Complainant did not indicate that there was any 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 without duplicating the report.The report was cleared and did not reoccur.An internal inspection of the device 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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