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Model Number 5833SL |
Device Problems
Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that when the cable was clipped to the lead and the electrical potential was viewed through the analyzer system, the electrocardiogram (ecg) showed negative injury current.When switched to another cable, the potential become positive.It was recommended that the cable be returned for analysis, but its current status is unknown.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: manufacturer's analysis confirmed the customer comment that the analyzer cable had incorrect continuity.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The cable was returned for analysis.
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Search Alerts/Recalls
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