MAUDE Adverse Event Report: RELIANT MEDICAL CHAIR; CHAIR AND TABLE, MEDICAL

Device Problem Mechanics Altered (2984)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/22/2021

Event Type  Injury  

Event Description

I was in the eye clinic at (b)(6) hospital.I was in a reclined position for an eye procedure.When the procedure was over the doctor pressed the button to raise the chair.The chair did not raise up.Only the headrest moved, grabbing my head and neck.It was quite strong.I was able to slide out quickly.(underneath) the 2nd incident was on july 22nd.It was much more severe.I received medical attention.Physical therapy and chiropractor.The 3rd episode occurred on august 16th.I told the eye doctor about my previous experience with the chair and to not raise it up.I would lift my self up manually.He forgot and activated the chair.Once again the chair malfunctioned.My head and neck were caught in the headrest.I went to the emergency room in the hospital.The back of my neck was swollen.The eye doctor said he had never seen this happen before.Fda safety report id# (b)(4).

• Brand Name: RELIANT MEDICAL CHAIR
• Type of Device: CHAIR AND TABLE, MEDICAL
• MDR Report Key: 15163696
• MDR Text Key: 297345011
• Report Number: MW5111273
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; INSULIN ASPART ; LISINOPRIL ; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White