Model Number ARD567911211C |
Device Problems
Overheating of Device (1437); Detachment of Device or Device Component (2907)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/12/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided upon results of investigation.Device not returned to manufacturer.
|
|
Event Description
|
On (b)(6) 2020 getinge became aware of an issue with one of our surgical light ¿ blue.As it was stated by the customer during the procedure part of the device has fallen down and additionally deformation of the device occurred due to overheating of the device.No injury was reported due to mentioned issue, however we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.Manufacturer's reference number: (b)(4).
|
|
Manufacturer Narrative
|
The issue is being investigated by the manufacturing site.
|
|
Event Description
|
Manufacturer's reference number (b)(4).
|
|
Manufacturer Narrative
|
Getinge became aware of an issue with one of our surgical light ¿ blue.As it was stated by the customer during the procedure part of the device has fallen down and additionally deformation of the device occurred due to overheating of the device.No injury was reported due to mentioned issue, however we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.It was established that when the issue occurred, the light head did not meet its specification and it contributed to the complaint as the cover shouldn¿t deform.In the time when the issue occurred the device was being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.We conclude that the issue is most likely caused by wrong maintenance of the device.This defect is visually detectable during the inspection performed by the users before any surgical procedure.Moreover, the bulb of the customer is different from the maquet bulb and has non-conforming technical specifications.An inappropriate bulb could damage the medical device.We believe the related devices are performing correctly in the market.
|
|
Event Description
|
Manufacturer's reference number (b)(4).
|
|
Search Alerts/Recalls
|