MAUDE Adverse Event Report: ACTIVEAID, LLC ACTIVEAID; 720 BARIATRIC REHAB SHOWER/COMMODE CHAIR

Model Number 720

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Photos of the issue were received by the manufacturer's quality management team on (b)(6) 2019.Pictures provided clearly show the powder coat finish has been worn away in the area where the brake is mounted on each side of the frame, exposing the bare stainless steel.It also shows piles of the powder coat finish along the edges of the clamps of the brake assembly, signifying that the brakes were sliding.Pictures also show the wheel lock foot to be bent at an angle, which typically has been shown to occur when the brake has been positioned too close to the wheel, creating excessive force on the assembly, or the screw in the wheel lock foot has loosened.The excessive force can move the brake assembly along the frame tubing.In two of the pictures there appears to be dark streaks or shadows along the bottom and side of the bare frame steel.It was not clear from the photographs that the frame itself was damaged and no longer round.Quality management reached out to the dealer regarding the condition of the frame on (b)(6) and received a reply on (b)(6) that the service technician said "he has tightened the brake assembly as tight as possible and they still move.He said yes that the frame is no longer perfectly cylindrical, therefore not holding onto the frame." during the follow up conversation with the user's son on (b)(6), he referenced a conversation with his mother regarding the recent service visit.The service technician was replacing the wheel bearings and brakes on the chair, and during reassembly was having problems locating the brakes back into the proper position.The service technician was unable to tighten the brakes properly and told the clients there was nothing they can do, and that they would need to purchase a new chair.She then asked her son for assistance with the issue.Also during the conversation with the user's son on (b)(6), he stated that the shower/commode chair is utilized in a handicap accessible home environment with hard surface flooring.There was no injury to the user when he experienced the issue of the chair moving during the transfer process, however they felt there was a potential for injury to him or his caretaker as he is unstable and could have experienced an uncontrolled fall from a standing height.During the investigation, when trying to duplicate the stated issue, tests were performed on the same frame and brake clamp components from another lot/or batch.The brake assembly clamp was mounted on the stainless steel frame tubing and squeezed from the sides of the clamp with 5,000 pounds of force and it did not cause any deformation of the steel frame tubing.The stainless steel screw fastener for the brake clamp (with the clamp positioned around the stainless steel frame tubing) was exposed to more than 3x the rated maximum torque for its grade before it broke and the clamp had not caused any damage to the frame.The frame and brakes were returned (b)(6) 2019.It was observed that the powder coat finish was worn away exposing the bare stainless steel frame in the area where the brake is to be mounted.The exposed frame was measured with a caliper and found to be within tolerance.The frame was not crushed, per the original issue description.During the investigation, the function of the brakes were checked and found to not function properly.The frame was manufactured in april 2015 and shipped to the dealer for their client on (b)(6) 2015.Dealer and client records indicate the chair was placed into service (b)(6) 2015.The expected service life of the frame is 3 years.The service life of the frame at the time of the reported issue was 4 years.This is the first and only recorded issue/complaint alleging deformation of the stainless steel frame tubing.The 720 has been manufactured since the year 2000, with over (b)(4) units distributed.The user was provided with a new frame and a new pair of brakes shipped via overnight delivery to the dealer on (b)(6).Tracking records indicate the package was delivered to the dealer (b)(6).In conversation with the dealer and user's son, the replacement frame and brakes were installed on or around (b)(6).During the follow up conversation with the user's son on (b)(6), he indicated that the new parts are working well and brakes are holding correctly when standing and sitting from the chair.

Event Description

Customer service received a phone call from the son of an activeaid product user monday (b)(6) regarding an issue with a 720 bariatric shower/commode chair.The son was upset as the dealer said activeaid had not been responding to the issue.He communicated that there was no injury, however he felt there was the potential for injury so he filed a report with the fda.Quality management returned his call that afternoon and received further information.The son said he filed a report with the fda as the frame was damaged (crushed) and the brakes were no longer securing the chair; based on the condition of the chair he felt it may result in a fall which could lead to a potential serious injury.

• Brand Name: ACTIVEAID
• Type of Device: 720 BARIATRIC REHAB SHOWER/COMMODE CHAIR
• Manufacturer (Section D): ACTIVEAID, LLC; 101 activeaid road; redwood falls MN 56283
• Manufacturer (Section G): ACTIVEAID, LLC; 101 activeaid road; redwood falls MN 56283
• Manufacturer Contact: amy curtis ; 101 activeaid road; redwood falls, MN 56283 ; 5076370812
• MDR Report Key: 8869406
• MDR Text Key: 164073885
• Report Number: 2126684-2019-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 132