Model Number 5392 |
Device Problems
Break (1069); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: analysis confirmed the reported issue; both output connectors were broken.Three case screws were also found to be contaminated.All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested.The device passed all final testing.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.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 the external pulse generator (epg) had damaged atrial and ventricular connectors.The epg has been returned for service.No patient complications have been reported as a result of this event.
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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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