MAUDE Adverse Event Report: UNKNOWN M51P BLUE BASE W/MK5 NX SPJ+ 9153642087; WHEELCHAIR, POWERED

Model Number M51

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Dealer alleges that oil is leaking from the motor/gearbox on left side.

• Brand Name: M51P BLUE BASE W/MK5 NX SPJ+ 9153642087
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4664037
• MDR Text Key: 5610802
• Report Number: 1525712-2015-02261
• 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
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2015
• 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