Model Number BOREA DR 1500 |
Device Problems
Inappropriate or Unexpected Reset (2959); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
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, after firmware update several resets (4) were reported at device interrogation.
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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, after firmware update several resets (4) were reported at device interrogation.
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Search Alerts/Recalls
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