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Model Number 8100 |
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 04/22/2024 |
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 represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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Event Description
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It was reported that the following issue was observed on the device: "won't run." additional notes provided by the facility¿s clinical engineering support services include: "won't run / right iui was bad replaced and calibrated the unit pass all test." reported problem cause description: "mechanical - electrical." there was no reported patient involvement.Although additional information and product return have been previously requested, the customer provided a general statement that ¿no further information will be provided, including patient demographics and no products will be returned.¿.
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Search Alerts/Recalls
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