CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI,US EN/FRN CA, CPR; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5S-90C |
Device Problem
Use of Device Problem (1670)
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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 prompted an "hv dump failure" message.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 including functionality testing without duplicating the report.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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