MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. ACTIVEAID; 600

Model Number 600

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

Event Type  Injury  

Event Description

On january 17, 2023 altimate medical, inc.Received an email from a customer alleging that the seat on his activeaid 600 caused damage to his anal sphincter, causing hemorrhoids and threatened pressure sores.Additionally, the customer alleged that the chair flips forward when he tries to get forward enough to void.Additional information was gathered from the customer and their medical equipment dealer regarding the issues during follow up communications.

Manufacturer Narrative

The device history record for the shower/commode chair was reviewed.The device shipped to the customer on 03/30/2023.The device was requested to be returned to altimate medical, inc via an rma for investigation.It was returned to altimate on 2/15/2024.The wear pattern of the seat indicates that it was not the proper seat selection for the clients needs.It appears that the client is sitting down into the seat with the ischial tuberosities (its) positioning on the area of transition from the seat opening to the slot opening.The seat openings are designed to allow most users its to float in the seat opening.The client may need additional foam thickness, a different shaped or sized opening and slot, or another foam option.The customer requested a replacement seat from their medical equipment dealer on 10/2/2023 and the dealer delivered the seat to the customer on 10/25/2023 (same part #).The client continued to use the device until the beginning of the year.The maintenance section of the owner's manual states "replace damaged or worn components.Contact your supplier for repair/replacement of said parts before continuing use of the shower/commode chair." the introduction section of the owner's manual contains the statements "it is necessary to inspect your shower/commode chair at least weekly to ensure it is in safe operating condition." and "this manual is an integral part of your shower/commode chair product and should be read completely and thoroughly by anyone that will be operating the unit." during attempts to recreate the forward tipping of the device, it was not possible to do so without the front casters being positioned to the rear, which is in contradiction to the insructions for use.The safety precautions section of the owner's manual contains the statement "extreme movements laterally or front to back may cause the unit to tip.These movements will cause a change to the normal center of gravity of the chair.It also contains the statement "when transferring or re-positioning in the chair, ensure casters are properly aligned (front casters in forward position, rear casters positioned to the rear) and wheel locks/caster locks are locked (as applicable to the configuration of the selected product)"and "do not use foot plates in the transfer process or when shifting your weight." a refund will be issued to the client as requested.

• Brand Name: ACTIVEAID
• Type of Device: 600
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• MDR Report Key: 18717448
• MDR Text Key: 335525834
• Report Number: 2183634-2024-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 600
• Device Catalogue Number: P13677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 01/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 86 KG