|
Model Number 8120 |
Device Problem
Calibration Problem (2890)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/13/2024 |
Event Type
malfunction
|
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 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 : no product will be returned.
|
|
Event Description
|
It was reported that the following issue was observed on the device: "came to lake park with no note." additional notes provided by the facility¿s clinical engineering support services include: "this unit was not passing its plunger force test.I recalibrated it and that fixed the issue.I ran the unit through all of its pm tests with no other problems." 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.¿.
|
|
Search Alerts/Recalls
|
|
|