MAUDE Adverse Event Report: MARCO / TAKAGI SEIKO CO., LTD. ENCORE AUTOMATIC EXAM CHAIR; CHAIR, OPHTHALMIC, AC-POWERED

Model Number 1220

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026)

Patient Problems Fall (1848); Paralysis (1997); Numbness (2415); Spinal Cord Injury (2432); Vertebral Fracture (4520)

Event Date 01/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, patient lost his sensation and inability to move all extremities after falling backward while sitting on a chair during an eye appointment.Provider needed to do a peripheral retinal exam and as the back of the chair was going back, in a slow, motorized fashion, the chair suddenly tipped backwards.Patient was sent to ed and ct full spine showed c5-c6 fracture.On the same day, patient had c2-t2 posterior spinal instrumented fusion (psif) and c5-c6 laminectomy.Patient is still in the hospital.The chair sits on a chair mover with unknown manufacturer, brand, and serial number."traumatic grade 2 anterolisthesis of c5 on c6 (9/38) with fracture through the ossified anterior longitudinal ligament, posterior longitudinal ligament, and intervertebral disc.The osseous spinal canal is severely narrowed at this level with presumed high-grade spinal cord injury and/or transection.The left c5-c6 facet joint is jumped.The right c5-c6 facet joint is perched with probable acute minimally displaced fracture of the right c6 superior articular pillar.This is a red dot policy injury." fda safety report id# (b)(4).

• Brand Name: ENCORE AUTOMATIC EXAM CHAIR
• Type of Device: CHAIR, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MARCO / TAKAGI SEIKO CO., LTD.; jacksonville FL 32224
• MDR Report Key: 13367155
• MDR Text Key: 284640551
• Report Number: MW5107016
• Device Sequence Number: 1
• Product Code: HME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White