Model Number 8100 |
Device Problems
Corroded (1131); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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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]];[ail sensor fault].There was no reported 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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Manufacturer Narrative
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Correction: describe event or problem.Annex b: b21.Annex c: c21.Annex d: d16.Additional information: remedial action required, remedial action # annex a: a040502.Annex b: b01.Annex c: c0601.Annex d: d01.Annex g: g02017.
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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];[ail sensor fault].There was no reported patient involvement.
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Search Alerts/Recalls
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