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Model Number ULYS DF4 DR - 2540 |
Device Problem
Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
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.
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Event Description
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Reportedly, the coil impedance was lower than 200 ohms in the remote report following a mri exam.
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Event Description
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Reportedly, the coil impedance was lower than 200 ohms in the remote report following a mri exam.
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Search Alerts/Recalls
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