MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIP. DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6795

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Customer just received the chair and does not feel that it is stable enough for their needs.Advised the customer to review page 18 of the manual on how to open the chair and install the seat.Customer states it was done right and it is just not stable enough.Customer states they contacted spinlife today and was told they would have to pay restocking fee and shipping.Advised customer to have spinlife contact us directly if they want to look into warranty possibility.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIP.
• MDR Report Key: 4234198
• MDR Text Key: 4977105
• Report Number: 1531186-2014-05424
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2014,10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2014
• Distributor Facility Aware Date: 10/20/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 11/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other