Model Number 8300 |
Device Problems
Break (1069); Crack (1135); Failure to Calibrate (2440); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device failed calibration test.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 failed calibration test.There was no patient involvement.
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Manufacturer Narrative
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Correction : annex b : b21.Annex c : c21.Annex d : d16.Additional information : device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?.Annex a : a0401, a0801.Annex g : g02017, g02013.Annex b : b01.Annex c : c070606, c0201.Annex d : d02.H3 other text : see manufacturer narrative.
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Event Description
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It was reported that the device failed calibration test.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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Search Alerts/Recalls
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