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

Model Number V18RLR

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

It was reported by the provider that the device arrived with a broken rear wheel.The provider also states there is no damage to the box the chair shipped in.No report of patient injury, no additional information provided.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4131183
• MDR Text Key: 4941427
• Report Number: 1531186-2014-04592
• 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: 09/30/2014,09/11/2014

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: V18RLR
• 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: 09/30/2014
• Distributor Facility Aware Date: 09/11/2014
• Device Age: 6 MO
• Date Report to Manufacturer: 09/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other