MAUDE Adverse Event Report: JUMAO MEDICAL EQUIPMENT MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number V18RFR

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2014

Event Type  No Answer Provided  

Event Description

Dealer advised seat upholstery is slumping or sagging in the middle.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): JUMAO MEDICAL EQUIPMENT; jiashan ; CH
• MDR Report Key: 3999022
• MDR Text Key: 16544870
• Report Number: 1531186-2014-03096
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/08/2014,07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V18RFR
• 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: 08/08/2014
• Distributor Facility Aware Date: 07/02/2014
• Device Age: 7 MO
• Date Report to Manufacturer: 08/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other