Model Number 8300 |
Device Problems
Failure to Read Input Signal (1581); Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
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 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 had failed in preventive maintenance.There was no patient involvement.
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Manufacturer Narrative
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Omit: a25 - no apparent adverse event (3189), g07001 - part/component/sub-assembly term not applicable, b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.
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Event Description
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It was reported that the device had failed in preventive maintenance.There was no patient involvement.
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Search Alerts/Recalls
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