MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIP PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED

Model Number M41SRB

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Type  malfunction  

Event Description

The dealer states the control box heated up to the point of smoking.This was the first chair and it was replaced with serial # (b)(4) which was ordered on (b)(6) 2013.The dealer claims this one had the same problem, and he finally replaced it with an m51.No information available on that chair.No other information is available.

• Brand Name: PRONTO M41 BLUE BASE 9153645762
• Type of Device: WHEELCHAIR, POWERED
• 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: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4434212
• MDR Text Key: 5372571
• Report Number: 3008262382-2015-00256
• 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: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M41SRB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2015
• 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