Catalog Number 425-00 |
Device Problem
Power Problem (3010)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/09/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) review did not show issues related to the complaint.The device was manufactured on 04/06/2015.A document assessment ((b)(4)) was conducted and no changes were required.The reported complaint cannot be confirmed since the device sample is not available to perform a proper investigation, determine the root cause and assign corrective actions.If the device sample becomes available at a later date, this complaint will be updated accordingly.
|
|
Event Description
|
The event is reported as: the unit shuts off during use.No harm or injury to patient reported.
|
|
Manufacturer Narrative
|
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.The unit failed the initial power connect test with a defective user interface pcb.When attempting to accept the unit settings the "check" light would not display.Considering the power control pcb (11801) is still driving all micro processing functions, this functional failure is indicative of a user interface pcb failure.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed a defective electronic component.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 25 sept 2012 and will be replaced.
|
|
Event Description
|
The event is reported as:
the unit shuts off during use.No harm or injury to patient reported.
|
|
Search Alerts/Recalls
|