Model Number 8015 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device will not turn on and logic board issue.There was no 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 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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Manufacturer Narrative
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Correction: 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 the device will not turn on and logic board issue.There was no patient involvement.
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Search Alerts/Recalls
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