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

Model Number CCFCA200

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

The seat hinges have broken so that the seat can't lock in place on back crossbar.

• Brand Name: CAREX
• Type of Device: UPLIFT COMMODE ASSIST
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 8608979
• MDR Text Key: 145013821
• Report Number: 3012316249-2019-00013
• Device Sequence Number: 1
• Product Code: ILS
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CCFCA200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/14/2019
• 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: Unknown
• Patient Sequence Number: 1