MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND FOOTRESTS; WHEELCHAIR, MECHANICAL

Model Number V18RFR

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The end user stated, the tire came off the rim when he was backing up the ramp.He was able to get the tire back on the rim but he does not know if he did any additional damage to the chair.

• Brand Name: VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND FOOTRESTS
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4348537
• MDR Text Key: 5138449
• Report Number: 1531186-2014-06535
• 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: Patient
• Type of Report: Initial
• Report Date: 12/17/2014,12/01/2014

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: V18RFR
• 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: 12/01/2014
• 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