Model Number 8300 |
Device Problems
Break (1069); Circuit Failure (1089); Crack (1135); No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
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 section h6 of 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 failed display test or light not working.There was no patient involvement.
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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 section h6 of 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.H3 other text : see manufacturer narrative.
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Event Description
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It was reported that the device failed display test or light not working.There was no patient involvement.
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Manufacturer Narrative
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**udi related data quality updates only** correction: unique device identifier (udi)# added pi to the unique device identifier (udi)# field.
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Event Description
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It was reported that the device failed display test or light not working.There was no patient involvement.
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Search Alerts/Recalls
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