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Model Number 2292 |
Device Problems
Under-Sensing (1661); Impedance Problem (2950); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2019 |
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, after a short time of use with the analyzer cables, the atrial channel showed too low of sensing and high impedance.It was noted that the sterilization and cleaning process was normal, and that it was only the atrial channel that was showing the malfunctions with the cables.The cables were replaced, and are expected to be returned.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: analysis was unable to confirm the customer comment of sensing and impedance issues on the atrial channel, however it was noted that the lock on the plug was broken off, the positive ventricular wire was broken and the positive ventricular alligator clip was no longer on the cable.The ventricular positive continuity tested "open" due to the damage but all other continuity tests were ok and no intermittent or shorted connections were found and there was correct resistance between pins 3 and 5.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 further reported that the product had been returned to service (both cables).
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Search Alerts/Recalls
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