Model Number 3105000306 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/14/2022 |
Event Type
Injury
|
Event Description
|
It was reported that there was a patient injury of a broken femur.
|
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
|
|
Manufacturer Narrative
|
The device manufacturer date is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: patient injury of a broken femur probable root cause: design * poor connector designs or tolerancing * connector is loose * connector unable to hold force * unclear feedback if mechanism is fully locked/attached * casters slip on floor * vertical spars collapse * horizontal spars collapse * fine traction element pivots unintentionally * boot disconnects from fine traction element * tabletop extension cushion lifts or slides under force use error the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
|
|
Event Description
|
It was reported that there was a patient injury of a broken femur.
|
|
Search Alerts/Recalls
|