Model Number AED PRO |
Device Problems
Self-Activation or Keying (1557); Failure of Device to Self-Test (2937)
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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 prompted a "unit failed" and "shock button stuck"messages.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 not received the device for evaluation and this complaint is still under investigation.
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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The customer's report of "self test failed" was observed and attributed to a stuck pin on the flex cable.The flex cable was replaced as a precaution.The device was recertified and returned to the customer.The customer's report of "critical errors observed in log" observed during review of the device data logs.The device was put through extensive testing without duplicating the report.The shock button gasket, shock switch retainer and shock button switch collar were replaced as a pre-caution.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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