Model Number MSERIES BI-PHASIC |
Device Problem
Device Displays Incorrect Message (2591)
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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 had "an ecg error in pacing mode".No further information was provided.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 device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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