MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. M61P BLUE BASE 9153653450; WHEELCHAIR, POWERED

Model Number M61PSR20B

Device Problems Material Discolored (1170); Electrical /Electronic Property Problem (1198); Melted (1385); No Device Output (1435); Sticking (1597); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation, and subsequent testing verified the complaint.Per the initial evaluation, the brake wire was melted to the brush holder; however, there was no visual evidence of melting on the exterior of the motor.There was no brake fault on the joystick when it was first hooked up during the bench test, but when attempting to drive, it gave the brake fault.An expanded evaluation was performed.Per the expanded evaluation report, when the motor/gearbox was connected to a test controller and joystick, there was a five-flash error code indicating a left park brake fault.Additionally, portions of the brake wiring were discolored and a section of the wiring was adhered to the brush, which caused a short in the brake circuit due to a wiring routing issue.Should additional information become available, a supplemental record will be filed.

Event Description

Dealer is stating that the end user put his m61 in the back of the van, and ever since the lights have been scrolling and the wrench flashing 6 times, left motor no output.The product was returned for evaluation, and subsequent testing verified the complaint.Per the initial evaluation, the brake wire was melted to the brush holder; however, there was no visual evidence of melting on the exterior of the motor.There was no brake fault on the joystick when it was first hooked up during the bench test, but when attempting to drive, it gave the brake fault.An expanded evaluation was performed.Per the expanded evaluation report, when the motor/gearbox was connected to a test controller and joystick, there was a five-flash error code indicating a left park brake fault.Additionally, portions of the brake wiring were discolored and a section of the wiring was adhered to the brush, which caused a short in the brake circuit due to a wiring routing issue.

• Brand Name: M61P BLUE BASE 9153653450
• 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: 5362998
• MDR Text Key: 36055956
• Report Number: 3008262382-2016-00036
• 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
• Report Date: 01/11/2016

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: M61PSR20B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/13/2016
• 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