Model Number G5A-02C |
Device Problems
High impedance (1291); Self-Activation or Keying (1557); Defibrillation/Stimulation Problem (1573); Output below Specifications (3004)
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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 not received the device for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during biomed testing, the device self discharged.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Device evaluation: the device was returned to zoll medical corporation; the customer's report was duplicated and attributed to damaged ecg circuitry on the main board.The main board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis for 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 self discharged, displayed a "bridge test failed" message, had defib out put that was out of specification and failed impedance testing.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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