Model Number 8015 |
Device Problems
Device Alarm System (1012); Corroded (1131); Crack (1135); Computer Operating System Problem (2898); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
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.H3 other text : see manufacturer narrative.
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Event Description
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It was reported that the device displayed an error code 800.8000.There was no patient involvement.
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Event Description
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It was reported that the device displayed an error code 800.8000.There was no patient involvement.
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Manufacturer Narrative
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Correction: annex a: a27.Annex g: g0200703, g02033.
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Event Description
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It was reported that the device displayed an error code 800.8000.There was no patient involvement.
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Search Alerts/Recalls
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