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 received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device's pacer rate could not be properly adjusted and intermittently stopped.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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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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