Model Number R SERIES |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Information (3190)
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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 while attempting to treat a patient (age & gender unknown), the device was unable to pace.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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Zoll medical corporation evaluated the device and the customer report was not replicated or confirmed.The device was put through extensive testing which included full pacer functionality testing without duplicating any malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.The clinical logs and electrode pads from the reported event were not returned for evaluation.Review of the device activity logs did not show any faults that could be associated with customer report.
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Search Alerts/Recalls
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