Catalog Number 8065750833 |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A customer reported that the system locked before surgery.
|
|
Manufacturer Narrative
|
The company service representative examined the system and was able to replicate and confirm the reported event.The nonconforming host controlled area network (can) controller printed circuit board (pcb) was replaced.As a preventative measure, the host card reader was replaced.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming host controlled area network (can) controller printed circuit board (pcb).The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
Additional information d.10., h.3., h.6.And h.10.The host controlled area network (can) controller printed circuit board (pcb) was received for evaluation.The returned sample was installed into a calibrated system hotbed.The system was able to boot-up without issues.The power up test was performed.The system was able to load and prime the cassette without issue.The host controlled area network (can) controller printed circuit board (pcb) functioned as intended; therefore the root cause of the reported event can be attributed to internal wear/reliability issues within the system.The root cause of the reported event can be attributed to internal wear or reliability issues within the system.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|