MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIP POWERED WHEELCHAIR; 890.3860

Model Number M41SRR

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

The dealer advised the left motor gear box is hot with a burning smell.There were no injuries and the dealer could not provide any further information.

• Brand Name: POWERED WHEELCHAIR
• Type of Device: 890.3860
• Manufacturer (Section D): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer (Section G): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4087963
• MDR Text Key: 4828989
• Report Number: 3008262382-2014-01049
• 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: 08/22/2014

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: M41SRR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/14/2014
• 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