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

Model Number M61PSR20B

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.The result of the evaluation was that the motor brush holders were tight causing the wheelchair to jerk, which confirmed the original complaint issue.However, there was no visual evidence of a grease leak, so the complaint of the gearbox leaking could not be confirmed.Should additional information become available, a supplemental record will be filed.

Event Description

The provider states the right gearbox is leaking grease and the chair was very jerky.The device was returned to the manufacturer for evaluation.The result of the evaluation was that the motor brush holders were tight causing the wheelchair to jerk, which confirmed the original complaint issue.However, there was no visual evidence of a grease leak, so the complaint of the gearbox leaking could not be confirmed.

• 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: 5254739
• MDR Text Key: 32408235
• Report Number: 3008262382-2015-01979
• 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: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: 11/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• 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