Model Number Z130 |
Device Problems
Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)
|
Patient Problems
Fall (1848); Injury (2348); Deformity/ Disfigurement (2360); Tooth Fracture (2428)
|
Event Date 10/19/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
After conducting a preliminary analysis and in house tests on similar devices, we believe it would be very unlikely that the user would manage to undo a properly functioning seat belt just by turning and wriggling as was reported by the user facility.The investigation is ongoing, but because we have not yet received the seat belt back for analysis, we are unable to reach a full conclusion at this time.We are actively pursuing return of the seat belt.
|
|
Event Description
|
It was reported that the user was strapped into the toilet chair using the seat belt.The user allegedly loosened the seat belt by turning and wriggling, and was able to move forward in the chair.The carer was unable to catch him in time, and he hit his face against a tiled wall.The user has had up to three teeth removed and will need facial reconstruction.
|
|
Manufacturer Narrative
|
The seat belt was not returned for inspection, but analysis of pictures of the belt in question show that the device was made and assembled correctly and that the device was not broken.In house testing on similar devices shows a very low likelihood of the user undoing the seat belt by turning and wriggling as was reported.It is our conclusion that either the seatbelt was improperly tightened, or the client loosened it with his hand.Safe use of the rifton hts depends on the presence of an attentive and responsible caregiver.In this incident it is apparent that adult supervision was insufficient.The device may also not be appropriate for the client.The product manual states "this product is intended for use by clients of unreliable judgment.Adult supervision is required at all times." and "a qualified professional must assess the appropriateness and safety of all equipment for each user.".
|
|
Search Alerts/Recalls
|