MAUDE Adverse Event Report: LPA MEDICAL INC. EVOLUTION MOBILITY CHAIR WITH LEFT SIDE LATERAL SUPPORT

Model Number S-150

Device Problems Break (1069); Detachment Of Device Component (1104); Failure to Align (2522); Device Operates Differently Than Expected (2913)

Patient Problems Ecchymosis (1818); Pain (1994); Fracture, Arm (2351)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

Resident noted to have pain in left shoulder on (b)(6) 2016 with fading yellow ecchymosis.X-ray obtained on (b)(6) 2016 that confirmed nondisplaced acute humeral neck fracture.Resident is severely demented and status post cva with hemiparesis of left side.During investigation, it was noted that on (b)(6) 2016, while activity assistant was transporting mrs.(b)(6) to the auditorium, she noticed her chair was leaning to the left.Pt did not exhibit pain at this time.Upon inspection of the chair, a wield that holds the back of the chair had detached causing the back of the chair to shift about 3 inches back and to the left.It is highly suspected that when the wield broke, the jerk of the movement could have caused the injury as there was just enough of an opening between the lateral support and the back of the chair for her upper arm to fall into.The location of the suspected fracture of her arm was where the lateral support was attached to the chair.In addition, pt had a previous fracture in 2015 at the same location of her arm.Pt had exhibited pain from time to time but staff thought it was her usual pain that she experienced and administered pain medication per orders.

• Brand Name: EVOLUTION MOBILITY CHAIR WITH LEFT SIDE LATERAL SUPPORT
• Type of Device: MOBILITY CHAIR
• Manufacturer (Section D): LPA MEDICAL INC.; 1940 country club road; long lake MN 55356
• MDR Report Key: 6190415
• MDR Text Key: 62938958
• Report Number: 6190415
• Device Sequence Number: 1
• Product Code: IOR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Distributor Facility Aware Date: 12/05/2016
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/14/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 54