CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, UK, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number G5A-02C |
Device Problems
Unable to Obtain Readings (1516); 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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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 bench handling, power cycling, and full functional testing without duplicating the report.The errors were cleared from the logs and did not re-occur.The electrode pads passed all testing.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 displayed a red "x" indicator and did not detect the electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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