Model Number 8120 |
Device Problems
Contamination (1120); Failure to Analyze Signal (1539); Device Markings/Labelling Problem (2911); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
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 failed barrel clamp test, logic board was replaced and device did not pass preventive maintenance.There was no patient involvement.
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Search Alerts/Recalls
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