MAUDE Adverse Event Report: INVACARE TAYLOR STREET M51P RED BASE W/MK5 NX SPJ+ 9153642088; WHEELCHAIR, POWERED

Model Number M51SCTRSTR

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The caller states that the cap fell off of the motor and leaked grease everywhere.The caller states nothing was damaged during the spill or on the chair.

• Brand Name: M51P RED BASE W/MK5 NX SPJ+ 9153642088
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4686642
• MDR Text Key: 5718152
• Report Number: 1525712-2015-02432
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51SCTRSTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• 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