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

Model Number M41SR20B

Device Problems Device Emits Odor (1425); Unintended System Motion (1430)

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

Event Date 02/01/2013

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

End user advised was driving chair on sidewalk when chair jerked to the right.Smelled burning wires and motor went out.End user advised was stranded.No further information.

• Brand Name: PRONTO M41 BLUE BASE 9153645762
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5675308
• MDR Text Key: 45788800
• Report Number: 3008262382-2016-00416
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M41SR20B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• 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 Age: 51
• Patient Weight: 109