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Model Number ULYS DF4 DR - 2540 |
Device Problems
Device Displays Incorrect Message (2591); Erratic Results (4059)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states.However; it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Please refer to the attached analysis report.
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Event Description
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Reportedly, there is an inconsistency in the rms report: ok coils, but with a value <200ohms.
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Search Alerts/Recalls
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