Model Number R 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 adjust pacer rate.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 evaluated by zoll (b)(4) service department.The malfunction was duplicated and the pace encoder cable was replaced to resolve the malfunction.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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