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 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 biomed testing the device displayed a "pacer fault 117" message.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; the malfunction was duplicated and the device's bridge board was replaced to resolve the condition.The customer declined repair of the device, therefore the device was returned and labeled not for clinical use.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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