Model Number MSERIES BI-PHASIC |
Device Problem
Output Problem (3005)
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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 biomed testing, the device was unable to adjust pacer rate and pacer output.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 (b)(4).The reported malfunction was observed during testing.However, the reported problem could not be duplicated.The control board was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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