|
Model Number V60 |
Device Problems
Device Displays Incorrect Message (2591); Failure to Shut Off (2939); Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2021.Date of report: 12mar2021.
|
|
Event Description
|
The customer reported the unit was connected to a patient in niv.Suddenly the device started alarming and gave an error message "turbine in neutral".After restarting, the screen was frozen and the unit gave another error message: the machine cannot be switched off.The customer contacted product support and requested for service repair.An intervention request was sent to the field team.The customer reported that the unit was in use on a patient, but there was no patient harm reported.The unit was swapped with a working unit.
|
|
Manufacturer Narrative
|
G4:12mar2021; b4:30apr2021.The field service engineer (fse) replaced the power management board per field change order to address the reported problem.All checks were carried out according to the manufacturer's recommendations.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
|
|
|