Model Number 8120 |
Device Problems
Crack (1135); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
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 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]];[fails functional test in the barrel clamp closed position].There was no reported patient involvement.
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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];[fails functional test in the barrel clamp closed position].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 a : a0404.Annex b : b01.Annex c : c0601.Annex d : d01.Annex g : g04037.
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Search Alerts/Recalls
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