Model Number MSERIES BI-PHASIC |
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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The reported malfunction and attributed the failure to an open wire (pin 2 patient end to pin 4 device end)-ground shield wire within the multi-function cable.The multi-function cable was replaced to resolve the malfunction.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that during biomed testing, the device's pacer output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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