|
Model Number V60 |
Device Problem
Failure to Run on Battery (1466)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2020.Date of report: 29dec2020.
|
|
Event Description
|
The customer called into technical support (ts) reporting that the device will not power on unless plugged into wall.The customer reported there was no patient involvement at the time the issue was discovered.The service technician evaluated the device and confirmed that it will not power on unless it is plugged into the wall, checked the battery and it does the same thing with known good battery, will need to order power management board to repair.
|
|
Manufacturer Narrative
|
G4: (b)(6) 2021.B4: (b)(6) 2021.The customer replaced the power management board to resolve the reported problem.The device will be placed back into service.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
|
G4:24feb2021.B4:01mar2021.H11:g5:k102985 h10: the customer ordered a new power management board to resolve reported problem.It was reported that once the part is received, the customer will replace the board and put the device back into service.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
|
|
|