SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
|
Back to Search Results |
|
Model Number 72200568 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/19/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that the light source had an e13 error code.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.The complaint of an e-13 error and overheating was confirmed.The ballast fan shut down after power up.Cause of overheating is a defective electronic component.The complaint investigation has concluded the cause of the failure to be a defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
|
|
Search Alerts/Recalls
|
|
|