ATAMA SYSTEM
Received Apr 20, 2021 · Event occurred Mar 18, 2021
Report 3009970070-2021-00008 · MDR key 11693755
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED AND REMAINS FUNCTIONAL AT THE SITE. IT WAS REPORTED THAT AN MRI TECHNICIAN BROKE HER RIGHT RING FINGER DURING THE TRANSFER OF THE ATAMA BOARD TO THE MRI BED. THE PATIENT WAS ON THE BOARD DURING THE TRANSFER. HER FINGER WAS WEDGED BETWEEN THE ATAMA BOARD AND THE MRI BED. THE FORCE CAUSED BY WEIGHT OF THE PATIENT ON THE BOARD CAUSED HER FINGER TO BREAK. THIS EVENT OCCURRED BECAUSE IFU/TRAINING INSTRUCTIONS WERE NOT FOLLOWED WHEN PLACING THE BOARD. THE TECH LIFTED THE ATAMA BOARD FROM THE PLASTIC PART AND DID NOT USE THE BLACK HANDLE. IT WAS ALSO REPORTED THAT THE TECH WAS A NEW EMPLOYEE, SO THEY MAY NOT HAVE HAD AS MUCH EXPERIENCE. THIS EVENT DID NOT IMPACT THE CASE.
Description of Event or Problem
DURING THE TRANSFER OF THE PATIENT FROM THE ATAMA BOARD TO THE MRI BED, THE MRI TECH BROKE A FINGER WHEN IT WAS IN BETWEEN THE ATAMA BOARD AND THE MRI BED.