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 product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device was unable to pace.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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Zoll medical (b)(4) evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.The pace/defib engine was replaced as precaution.The device was recertified and returned to the customer.No product was returned to zoll medical us for evaluation.No trend is associated with reports of this type.
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Search Alerts/Recalls
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