Model Number MESE1 |
Device Problems
Difficult or Delayed Activation (2577); Ventilation Problem in Device Environment (3027)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure that the unit reads rf activation port not recognizing.Unable to test.The unit continues to run or does not run at all.
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Manufacturer Narrative
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(b)(4).Unknown, assumed 1st day of month that the event took place.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.
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Manufacturer Narrative
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(b)(4).Date sent: 5/5/2022.Investigation summary : per service manual operational and diagnostic analysis confirmed the rf activation port was not recognizing.The pcb assembly board and damping unit spring motor were replaced as identified in the investigation to address the issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The repair and testing of the unit was completed.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
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Search Alerts/Recalls
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