MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number M51PSR20R

Device Problem Mechanics Altered (2984)

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

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Left motor will lock intermittently while driving.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The left motor/gearbox was returned for evaluation, however subsequent testing could not verify the complaint.Per the initial evaluation, the motor did not lock during the bench test.The wires and clutch handle were wiggled with no failure.However, it was unable to be tested under load.An expanded evaluation was performed.Per the expanded evaluation report, the alleged failure was tested by connecting the motor/gearbox to a test controller and joystick and positioning the inductive of the joystick in forward, reverse, right, and left for a duration of 5 minutes, in each direction, at maximum speed.There was no observed lag or stoppage of the output shaft in any direction.

Event Description

Left motor will lock intermittently while driving.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5267041
• MDR Text Key: 32933104
• Report Number: 3008262382-2015-01994
• Device Sequence Number: 1
• Product Code: ITI
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51PSR20R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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