LIBERTY
Received Dec 13, 2022 · Event occurred Oct 27, 2022
Report 3005905321-2022-00001 · MDR key 15970335
Device
Product problems
- Missing Information
- Missing Information
Patient
Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
WHILE THE CHAIR WAS BEING TILTED, THE END USER'S FINGER WAS INJURED BY BEING PINCHED NEAR THE WHEEL LOCK. END USER'S HAND WAS IN THE AREA OF THE FRAME/WHEEL LOCK WHEN BEING TILTED. ALLEGED EVENT OCCURRED AT (B)(6) FACILITY DURING REHAB. AS PART OF THE INVESTIGATION, IT WAS DETERMINED THAT THE OWNER'S MANUAL INCLUDES WARNINGS OF THE PINCH POINTS IN QUESTION AND WAS PROVIDED TO THE END USERS' CAREGIVER AT DELIVERY OF THE WHEELCHAIR.
Additional Manufacturer Narrative
AN INCIDENT OCCURRED ON (B)(6) 2022 THAT RESULTED IN A COMPRESSION OF THE DISTAL PHALANGES WHEN THE PATIENTS FINGER WAS TRAPPED BETWEEN THE BUMPER, SEAT FRAME AND THE SEAT FRAME OR BETWEEN THE BUMPER, SEAT FRAME MOUNT AND SEAT FRAME DURING TILT POSITIONING. DUE TO THE SEVERITY OF THE ALLEGED INCIDENT, THIS REPORT IS BEING FILED WHILE THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
IT WAS DETERMINED BY THE INVESTIGATION OF THIS ADVERSE EVENT THAT ADDITIONAL PINCH POINT LABELING WAS NEEDED TO WARN USERS OF AN ORIGINALLY UNRECOGNIZED POTENTIAL HAZARD. AN ECO WAS INITIATED, TWO ADDITIONAL PINCH POINT LABELS WERE ADDED TO THE DEVICE, AND ADDITIONAL PINCH POINT WARNINGS WERE ADDED TO THE OWNER'S MANUAL FOR THE DEVICE.
Description of Event or Problem
WHILE THE CHAIR WAS BEING TILTED, THE END USER'S FINGER WAS INJURED BY BEING PINCHED NEAR THE WHEEL LOCK. END USER'S HAND WAS IN THE AREA OF THE FRAME/WHEEL LOCK WHEN BEING TILTED. ALLEGED EVENT OCCURRED AT (B)(6) FACILITY DURING REHAB. AS PART OF THE INVESTIGATION, IT WAS DETERMINED THAT THE OWNER'S MANUAL INCLUDES WARNINGS OF THE PINCH POINTS IN QUESTION AND WAS PROVIDED TO THE END USERS' CAREGIVER AT DELIVERY OF THE WHEELCHAIR.
Remedial action
- Replace