MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. ACTIVEAID; 285TR SHOWER/COMMODE CHAIR

Model Number 285TR

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

The shower/commode chair was manufactured and shipped to the dealer in april of 2022.This is the first recorded issue/complaint for the tilt/recline assembly used for this chair.Based on product history there are no trends to indicate a product issue.During the investigation, when trying to duplicate the stated issue, tests were performed on the same chair from another lot/or batch and also the client's chair in the condition as it was returned.It was noted that even with only 1 of the 2 gas springs from the recline assembly attached, that the chair's recline function continued to work.It was also able to lock and hold in the upright position.One of the factors assessed during testing included the ability of the chair back to go backwards freely from the upright position with only 1 of the 2 gas springs of the recline assembly connected.During the investigation, it was found that even if the chair had only 1 gas spring attached, from the upright position excessive force needs to be applied into the back.To overcome the gas spring to allow it to go freely backwards.It was also found that the application of this excessive force duplicated the damage to the right gas spring observed from the client's returned unit.Considering if the care giver could have been mistaken and the back was in a slight recline position (approximately 15 degrees) instead of completely upright a test was conducted to determine its function in that position with only 1 gas spring assembly.Testing found that even when the back was in an approximately 15 degree recline and half of the maximum user weight (175lbs) was placed onto the back for a 20 minute static test with only 1 gas spring assembly connected, that the back held the recline position.The failure is determined to be due to abnormal usage of the chair on two fronts.One it was stated during the conversation with the dealer that the staff caring for the client used the chair after they had identified and alerted him regarding an issue with the chair.It was after the issue was identified that they client was put into the chair and the incident occurred.Second, it was stated that the user was in the upright position when the gas spring broke and the back went backward, however experiments to recreate the issue could not be duplicated without excessive forces being applied.The application of excessive force without actuation of the recline mechanism may damage the hardware and then the gas spring.The safety precautions section on page 2 of the owner's manual states: "caution: check all fasteners before operating." it also states "caution: it is necessary to periodically check all fasteners (snap buttons, screws, nuts, bolts, clips, pull pins, handles, etc.) to ensure they are secure." the maintenance section on page 8 of the owner's manual outlines that the product should discontinue being used if damaged or worn components are identified, "replace damaged or worn components.Contact your supplier for repair/replacement of said parts before continuing use of the shower/commode chair." proper usage of the tilt and recline functions are outlined on page 6 of the owner's manual in the usage section."tilt function-adjust the tilt-in-space angle position of the device by lifting on the lock release handle to disengage the locking mechanisms.Lift up or push down on the handle of the back assembly to tilt the device to the position.There is a step on the back to assist with putting the chair in the tilt position.Release the lock release handle to lock and secure the device in place.Recline function-adjust the recline position of the device by lifting on the lock release handle to disengage the locking mechanisms.Lift up or push down on the handle of the back assembly to recline the device to the desired position or bring back to non-reclined position.Release the lock release handle to lock and secure the device in place." labeling also exists on product as "caution: check all fasteners before use." labeling also exists on the product to indicate which handle is to be used for the tilt function and which is to be used for the recline function.The offer to provide a new replacement 285tr shower/commode chair has been accepted and the client will be provided with a new chair.

Event Description

Customer service received a phone call from a dealer on wednesday (b)(6) 2022 regarding an issue with a client's 285tr shower/commode chair.He had been told that the client was sitting upright in the chair with the back at 90 degrees, a gas spring broke and the back folded backwards.The client fell out of the chair, sustained a cut to their leg, was taken to the er and received stitches.The dealer provided photographs of the chair to customer service.Customer service shared the information with quality management, who worked with the dealer to receive further information about the incident and the chair.Quality management received the following further information.The caretakers of the client had reported to the dealer that morning of the incident (prior to the incident occurring) that there was a bolt that was about to break on the chair, however by the time the dealer made it to the client's facility later that day, the chair had been used with the client and the incident occurred and the client had been taken to the er.

• Brand Name: ACTIVEAID
• Type of Device: 285TR SHOWER/COMMODE CHAIR
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• Manufacturer (Section G): ALTIMATE MEDICAL, INC; 101 activeaid road; redwood falls MN 56283
• Manufacturer Contact: amy curtis ; 262 west first street; morton, MN 56270 ; 5076370812
• MDR Report Key: 14889574
• MDR Text Key: 295223423
• Report Number: 2183634-2022-00001
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 285TR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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 Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 125 KG