MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT T93AC; FOOTREST, WHEELCHAIR

Model Number T93HE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported by dealer that monthly, he receives a box of foot plates and elevating leg rests that are broken from a hospital that he sold a high quantity of chairs.The dealer stated the foot plates are cracked and broke.

• Brand Name: T93AC
• Type of Device: FOOTREST, WHEELCHAIR
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4326264
• MDR Text Key: 5245224
• Report Number: 1531186-2014-06242
• Device Sequence Number: 1
• Product Code: IMM
• 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: 12/11/2014,11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T93HE
• 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: 12/11/2014
• Distributor Facility Aware Date: 11/18/2014
• Device Age: 19 MO
• Date Report to Manufacturer: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other