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Model Number 5487 |
Device Problems
Connection Problem (2900); Output Problem (3005)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 10/20/2016 |
Event Type
Injury
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Event Description
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It was reported before coronary artery bypass surgery, a cable had been placed and plugged in to an external pacemaker.During the procedure, the product showed a dysfunction which caused the patient cardiac arrest.It had been replaced by another of the same lot which presented the same default.The plug between electrodes and wire connection seemed to be deficient.When the connection was moved, sometimes it worked again.During this, the patient received an internal heart massage.Finally the cable was replaced by a different model cable.The cables were returned for analysis.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: manufacturer's analysis was unable to confirm the customer comments regarding the cable.During analysis the cable passed all visual incoming inspection with no anomalies found, and the cable passed all continuity tests with no intermittent or shorted connections found.
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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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Search Alerts/Recalls
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