Model Number TABLETOP |
Device Problem
Optical Problem (3001)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
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 the system's illumination light bulb was dim.
|
|
Manufacturer Narrative
|
Corrected information provided in h10.Additional information provided in d9, not in d10 as previously reported.The manufacturer internal reference number is:(b)(4).
|
|
Manufacturer Narrative
|
The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent system update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The company service representative examined the system and replicated the reported event.The non-conforming xenon lamp was replaced to resolve the issue.Unrelated to the reported event, the card reader printed circuit board (pcb) and vitrectomy valve cable were replaced.The system was then tested and met all product specifications.The system was manufactured on (b)(6) 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the non-conforming xenon lamp.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|