MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPEASY SEAT ASSIST (PLUS)

Model Number CCFUPE3

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Patient attempts to sit down on the up-easy seat, but it goes back up and thrusts the patient forward.It is unknown if the patient had the device on their correct weight setting.

• Brand Name: CAREX
• Type of Device: UPEASY SEAT ASSIST (PLUS)
• 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: 9948692
• MDR Text Key: 199693652
• Report Number: 3012316249-2020-00015
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CCFUPE3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• 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: Unknown
• Patient Sequence Number: 1