Model Number 8100 |
Device Problems
Contamination (1120); Crack (1135); Failure to Power Up (1476); Device Sensing Problem (2917)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/28/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the device will not power on.There was no patient involvement.
|
|
Manufacturer Narrative
|
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 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.See manufacturer narrative.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that the device will not power on.There was no patient involvement.
|
|
Search Alerts/Recalls
|