MAUDE Adverse Event Report: INVACARE CANADA KIRKLAND DEMO 1 MYON FOLDING WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number DEMO1MYON

Device Problems Bent (1059); Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Provider states the crossbraces do not fit down into the h block because the center bolt in the crossbrace is bent.

• Brand Name: DEMO 1 MYON FOLDING WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE CANADA KIRKLAND; 16769 hymus blvd.; kirkland qc H9H 3 L4; CA H9H 3L4
• Manufacturer (Section G): INVACARE CANADA KIRKLAND; 16769 hymus blvd.; kirkland qc H9H 3 L4; CA H9H 3L4
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5697036
• MDR Text Key: 47734400
• Report Number: 3002416487-2016-00043
• Device Sequence Number: 1
• Product Code: IOR
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEMO1MYON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• 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