|
Model Number 8300 |
Device Problems
Material Fragmentation (1261); Power Problem (3010)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.Based on the findings, service determined that the proximate cause of the reported issue was due to a loose j3 cable causing error code 571.6240.A review of the device history record for (b)(4) was performed from (b)(6) 2016 to (b)(6) 2020 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.
|
|
Event Description
|
It was reported that the device displayed alarm error codes/messages as a calibration error.There was no patient involvement.
|
|
Manufacturer Narrative
|
Add b5, g4, h6 (conclusion), correct g7, h6(results).
|
|
Event Description
|
It was reported that the device displayed alarm error codes/messages as a calibration error.There was no patient involvement.
|
|
Event Description
|
It was reported that the device displayed alarm error codes/messages as a calibration error.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|