|
Model Number V60 |
Device Problem
Failure to Align (2522)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2020.Date of report: 27oct2020.
|
|
Event Description
|
The customer reported that the right bottom part on the screen was misaligned even when the touch screen was calibrated.The customer contacted product support and requested for service repair.The customer reported that the unit was not in use on a patient.
|
|
Manufacturer Narrative
|
G4:23dec2020.B4:31dec2020.The service technician replaced the touchscreen to address the reported issue.The unit passed all testing.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|
|
Manufacturer Narrative
|
G4:18feb2021.B4:24feb2021.H11:g5:k102985.H10: failure analysis on the returned touchscreen shows that the ul_lr / ur_ll resistance were out of spec.Fault are found on this returned touchscreen.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|
|
Search Alerts/Recalls
|
|
|