Model Number 8110 |
Device Problems
Break (1069); Contamination (1120); Corroded (1131); Crack (1135); Degraded (1153); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
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Event Description
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It was reported that the device had error codes/messages.There was no patient involvement.
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Manufacturer Narrative
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Correction to remove the semdr mfr report # 2016493-2023-145224.After further review, it was determined the report was submitted in error.
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Event Description
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It was reported that the device had error codes/messages.There was no patient involvement.
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Manufacturer Narrative
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This semdr is automatically created upon completion of investigation.However, since it does not impact the already filed emdr, we need to cancel this auto created semdr.
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Event Description
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It was reported that the device had error codes/messages.There was no patient involvement.
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Search Alerts/Recalls
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