Catalog Number STK-SD-001 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/02/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the receiver ceased to function.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The product was evaluated.An external visual inspection was performed and passed.Receiver charged and will boot was performed and failed due to receiver does not power on.Perform internal visual inspection and passed.The log was not downloaded for review because the unit did not power on after charging.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
|
|
Search Alerts/Recalls
|