Model Number MSERIES BI-PHASIC |
Device Problem
Unable to Obtain Readings (1516)
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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 a routine shift check by a clinician, the device was unable to obtain an ecg signal.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included bench handling and stress testing without duplicating the malfunction.The device was recertified and returned to the customer.The ecg cable used during the reported event was not returned for evaluation.No trend is associated with reports of this type.
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Search Alerts/Recalls
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