Model Number MSERIES BI-PHASIC |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
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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 follow-up report when our investigation is completed.
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Event Description
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Complainant alleged that during a biomed testing, the device was unable to obtain ecg signal via multifunction cable.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation; visual evaluation of the device found damage consistent with tampering.Due to the condition in which the device was received, root cause analysis could not be performed.The device was repaired and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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