MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558; WHEELCHAIR, MECHANICAL

Model Number TREX28RP

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that when the end user wants to turn left or back up in a trex28rp wheelchair, the left rear wheel does not grip.The wheel just spins on the carpet.

• Brand Name: TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4383922
• MDR Text Key: 17218880
• Report Number: 1531186-2015-00020
• 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: 01/05/2015,12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX28RP
• 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: 01/05/2015
• Distributor Facility Aware Date: 12/11/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 01/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other