Model Number R SERIES |
Device Problem
Output Problem (3005)
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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's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical singapore; the customer's report was duplicated and attributed to the pace/defib engine board.The pace/defib engine board was replaced to resolve thge 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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Manufacturer Narrative
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The pace/defib board was returned for evaluation.The customer's report was duplicated and attributed to a charging cap on the pace/defib engine board.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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