MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564; WHEELCHAIR, MECHANICAL

Model Number TRSX58FBP

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 frame on a trsx58fbp wheelchair is tweaked and will not sit level.The dealer stated that the front right caster wheel does not touch the ground.

• Brand Name: TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4339488
• MDR Text Key: 5216852
• Report Number: 1531186-2014-06427
• 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: 12/16/2014,10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX58FBP
• 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: 10/30/2014
• 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