MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIP. MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number TRAN19FR

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2014

Event Type  No Answer Provided  

Event Description

It was reported by the consumer that the incorrect front rigging was sent out.When locking the front riggings into place, the footplates are facing the opposite directions.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIP.
• MDR Report Key: 3973294
• MDR Text Key: 4627853
• Report Number: 1531186-2014-02935
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2014,06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRAN19FR
• 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: 07/30/2014
• Distributor Facility Aware Date: 06/24/2014
• Date Report to Manufacturer: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other