Model Number MSERIES BI-PHASIC |
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 and the battery used were returned to a zoll third party service provider and the customer's report was not replicated or confirmed.The device and battery were subjected to a full system functionality test without duplicating the report.The device was recertified and returned to the customer.No clinical data was received 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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