|
Model Number NGP680300 |
Device Problems
Computer Software Problem (1112); Fire (1245); Unexpected Shutdown (4019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Section a2, a4 and a5: requested information and it was not provided.Section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.Device evaluation: the phaco system was evaluated by a field service engineer (fse) and replaced the base charge control panel.The system is performing to specifications.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Event Description
|
Customer reported that their whitestar signature system emitted smoke and shut down mid case.System restarted itself and displayed error codes.No patient injury and procedure was completed with backup system.No further information provided.
|
|
Manufacturer Narrative
|
Corrected data - section h4, device manufacture date, mar 16, 2011.Section h10, additional data - through follow up it was determined that the machine started smoking before it came in contact with the patient.It was sequestered before it had patient contact.No further information provided.Section h6, component code - 765 - controller, 3032 - battery charger.Section h6, investigation findings, 180 - mechanical problem identified.Section h6, type of investigation, 3331 - analysis of production records, 4109 - historical data analysis.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Search Alerts/Recalls
|
|
|