Model Number X SERIES |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Patient Involvement (2645)
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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 functional testing, the device was unable to pace.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 (b)(4) service department.The reported malfunction was observed during review of the device history logs.However, the reported problem could not be duplicated with the device.The processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.The accessories 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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