MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT VERANDA 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935; WHEELCHAIR, MECHANICAL

Model Number V16RLR

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that the right side wheel of a v16rlr wheelchair is warped.

• Brand Name: VERANDA 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4353124
• MDR Text Key: 5219861
• Report Number: 1531186-2014-06688
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/16/2014,10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V16RLR
• 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: 12/16/2014
• Distributor Facility Aware Date: 10/31/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other