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

Model Number TRAN19FR

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  No Answer Provided  

Event Description

Per dealer, left wheel lock and back release levers are loose and fell off.Release lever is not available as a part so whole chair needs to be replaced.(b)(4).

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIP.
• MDR Report Key: 4036895
• MDR Text Key: 19300389
• Report Number: 1531186-2014-03500
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/22/2014,08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/22/2014
• Distributor Facility Aware Date: 08/04/2014
• Device Age: 8 MO
• Date Report to Manufacturer: 08/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other