MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT VERANDA 18 IN X 16 IN FRAME W/REM DESK LENGTH ARMS AND ELEV LEGRESTS; WHEELCHAIR, MECHANICAL

Model Number V18RLR

Device Problems Out-Of-Box Failure (2311); 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 frame on the left side of a v18rlr wheelchair seems warped out of the box.The dealer cannot adjust the wheel lock to make the wheel not hit the frame.

• Brand Name: VERANDA 18 IN X 16 IN FRAME W/REM DESK LENGTH ARMS AND ELEV LEGRESTS
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4348600
• MDR Text Key: 17939968
• Report Number: 1531186-2014-06544
• 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: 12/17/2014,11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V18RLR
• 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: 12/17/2014
• Distributor Facility Aware Date: 11/04/2014
• Device Age: 2 MO
• Date Report to Manufacturer: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other