Model Number 5392 |
Device Problems
Break (1069); Nonstandard Device (1420); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Non-healthcare professional.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 a broken connector.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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Product analysis: analysis was unable to confirm the customer comment that the generator had a broken ventricular connector however it was noted that the output connector assembly was contaminated.It was additionally noted that the display flex trace was damaged, the tube was missing and that two output connector nuts and five case screws were contaminated.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.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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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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