MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPLILFT COMMODE ASSIST

Model Number CCFCA200

Device Problem Misassembly by Users (3133)

Patient Problem Fall (1848)

Event Date 01/24/2020

Event Type  malfunction  

Event Description

The initial reporter's husband went to sit on the device and put his hand on the rails and it went sideways.He fell down but he didn't get hurt.She had to use a patient lift to get him up.It had a side to side movement before he lost his balance and fell onto the commode assist.He was standing in front of it with both hands on the arms.When he went to turn around to sit on it he lost his balance and fell onto the commode assist.It bent when he fell on it.This device must be assembled by the end-user.On page 1 of the instructions under "safety precautions, warning!" it states after the fourth bulletin "before using the unit, double-check all fasteners to ensure they are tight." the next bulletin states "safety first: we strongly recommend that the person who assembles the commode assist, be it a home medical equipment retailer or caregiver, "try out" the commode seat by seating and raising themselves before the user.This is to ensure that all connections have been made securely and that the commode assist will be safe for the user." it also states "note: it is recommended that you check all hardware periodically.".

• Brand Name: CAREX
• Type of Device: UPLILFT COMMODE ASSIST
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights, ; 2682110
• MDR Report Key: 9741664
• MDR Text Key: 206150785
• Report Number: 3012316249-2020-00010
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CCFCA200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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