MAUDE Adverse Event Report: INVACARE SUZHOU POWERED WHEELCHAIR; 890.3860

Model Number M51PSEMIBLUE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Dealer stated that the joystick on a m51psemiblue power chair stops after going over a bump, flashes an error code.

• Brand Name: POWERED WHEELCHAIR
• Type of Device: 890.3860
• Manufacturer (Section D): INVACARE SUZHOU; unit 28 zone,200 suhong rd; suzhou industrial park; jiangsu, p.r.c. 2150 21; CH 215021
• Manufacturer (Section G): INVACARE SUZHOU; unit 28 zone,200 suhong rd; suzhou industrial park; jiangsu, p.r.c. 2150 21; CH 215021
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3816925
• MDR Text Key: 4498902
• Report Number: 3004493922-2014-00743
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51PSEMIBLUE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other