Model Number 8100 |
Device Problems
Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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.H3 other text : device was not returned to manufacturing facility.
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Event Description
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It was reported that the device had blown fuse on the board.Upon inspection, it was found that the value of the fuse installed on the board is 750ma, while the fuse that should be according to service manual is 7.5a 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.H3 other text : customer provided sample photo only.No device was returned.
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Event Description
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It was reported that the device had blown fuse on the board.Upon inspection, it was found that the value of the fuse installed on the board is 750ma, while the fuse that should be according to service manual is 7.5a.There was no patient involvement.
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Search Alerts/Recalls
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