Model Number 8110 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2023 |
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 a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[[service type]]; device shows with recalibration error despite having maintenance done.There was no reported patient involvement.
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Manufacturer Narrative
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Correction: describe event or problem annex b: b21 annex c: c21 annex d: d16 additional information: annex b: b17 annex c: c20 annex d: d15.
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Event Description
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It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[depot repair];[device shows with recalibration error despite having maintenance done].There was no reported patient involvement.
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Search Alerts/Recalls
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