Model Number 8015 |
Device Problems
Break (1069); Corroded (1131); Crack (1135); Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.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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Event Description
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It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.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.
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Search Alerts/Recalls
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