Model Number 8300 |
Device Problems
Break (1069); Crack (1135); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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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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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 in preventive maintenance.There was no patient involvement.
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Manufacturer Narrative
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Correction: annex c: c07; annex d: d01.
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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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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 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.See manufacturer narrative.
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Search Alerts/Recalls
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