MAUDE Adverse Event Report: INVACARE CANADA KIRKLAND TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number MYONADLT

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Ball at the center of the quick release axle has broken off.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Other, other/defective.One of the connect balls on the quick release axle was missing.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Other, other/defective.One of the connect balls on the quick release axle was missing.Ball at the center of the quick release axle has broken off.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• 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: 5285267
• MDR Text Key: 33729222
• Report Number: 3002416487-2015-00128
• 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,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MYONADLT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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