MAUDE Adverse Event Report: INVACARE FRANCE OPERATIONS KUSCHALL CHAMPION; MECHANICAL (MANUAL) WHEELCHAIR

Model Number EU:-CHAMPION_08_CFG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 07/21/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u.S.The end user was contacting kuschall to inquire about aftermarket components not offered at the time he was originally ordering his chair.During the phone call he off handedly mentioned the incident.There was no alleged malfunction of the kuschall device.The wheelchair is currently still in use and not being returned.The end user was using a non-kuschall power assist accessory at the time of the event.The owner's manual has warnings regarding using non-kuschall accessories stating: "use of non-küschall accessories may result in serious injury or damage.Küschall products are specifically designed and manufactured for use in conjunction with küschall accessories.Accessories designed by other manufacturers have not been tested by küschall and are not recommended for use with küschall products.Do not use non-küschall accessories." it also states: "do not operate on roads, streets or highways.There is a risk of skidding on wet ground, gravel or uneven terrain.Always adjust your speed and driving style to the conditions (weather, surface, individual ability, etc.)".

Event Description

End user was on the road, headed downhill, when one or both front casters were blocked by a little stone causing him to be thrown from the chair.The end user sustained a laceration to the head and two broken ribs.

• Brand Name: KUSCHALL CHAMPION
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): INVACARE FRANCE OPERATIONS; route de st roch; fondettes 37230 ; FR 37230
• Manufacturer (Section G): INVACARE FRANCE OPERATIONS; route de st roch; fondettes 37230 ; FR 37230
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44036 ; 8003336900
• MDR Report Key: 7812710
• MDR Text Key: 118124249
• Report Number: 8020801-2018-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EU:-CHAMPION_08_CFG
• Device Catalogue Number: CHAMPION_08_CFG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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