Model Number 8120 |
Device Problems
Calibration Problem (2890); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2023 |
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 had failed calibration.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: a25.Annex b: b01.Annex c: c19.Annex d: d15.Annex g: g07001.
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Event Description
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It was reported that the device had failed calibration.There was no patient involvement.
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Search Alerts/Recalls
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