MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TREX2/WD06/ADULT/28/U67/BH16/U2222C 9153653552; WHEELCHAIR, MECHANICAL

Model Number TREX20RP

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that brand new out of box failure.Dealer states there is a defect where the footrest attaches to the frame on the (b)(4) wheel chair.The footrest will not click into place on the frame due to the part is die cast incorrectly.No patient involvement, brand new chair.

• Brand Name: TREX2/WD06/ADULT/28/U67/BH16/U2222C 9153653552
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4519995
• MDR Text Key: 5495423
• Report Number: 1531186-2015-01006
• 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: 02/16/2015,02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX20RP
• 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: 02/16/2015
• Distributor Facility Aware Date: 02/09/2015
• Device Age: 6 MO
• Date Report to Manufacturer: 02/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other