Model Number UHI-4 |
Device Problems
Intermittent Continuity (1121); No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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During an asset return inspection with no complaint from the customer, an error code e03 was observed on the device.There was no patient involvement on this reported event.No user injury reported.
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Manufacturer Narrative
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Device evaluation and inspection, service repair noted the following findings: error e03 observed intermittently likely due to faulty main board (printed circuit board failure).Additionally, housing inspection found scratches on top cover.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿ investigation is ongoing.This report will be supplemented accordingly following investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported e03 error code which indicates an abnormal pressure sensor.A review of the device history record (dhr) found no deviations that could have caused or contributed this issue.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because of the main internal circuit board was faulty.The root cause of the fault was unknown.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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