Model Number 8015 |
Device Problems
Failure to Read Input Signal (1581); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/08/2023 |
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 an 8015 pcu was affected by keypad recall.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 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 an 8015 pcu was affected by keypad recall.There was no reported patient involvement.
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Search Alerts/Recalls
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