MAUDE Adverse Event Report: UNKNOWN POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number UNKNOWN

Device Problems Break (1069); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The service tech states the seal for the motor has came off and states the motor was smoking.He states the broken seal caused the grease to migrate from the gearbox to the motor.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• 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: 5094556
• MDR Text Key: 26639423
• Report Number: 1525712-2015-04602
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Patient
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• 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