SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
|
Back to Search Results |
|
Model Number 72200568S |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/26/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference case - (b)(4).
|
|
Event Description
|
It was reported that the light source could not power on, probably because of a bad power supply.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).H10: h2, h3, h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.Complaint of power up failure was confirmed.Cause of power failure is a defective power supply/ballast.Unit powered up and passed functional testing with a known good power supply installed.The complaint investigation has concluded the cause of the failure to be a defective electronic component.The device has been in service for over 6 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.
|
|
Search Alerts/Recalls
|
|
|