MAUDE Adverse Event Report: KUSCHALL DESIGN AG KUSCHALL K-ATTRACT; MECHANICAL (MANUAL) WHEELCHAIR

Model Number NA:DDZ0068

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

The chair was not returned due to no defect or malfunction related to the wheelchair was alleged.  the anti-tips were removed by the user to be cleaned and the user did not reinstall.The user manual has warnings  that state: "risk of accidents - safety devices that are incorrectly set or no longer working (brakes, antitipper) can cause accidents.Always check that the safety devices are working before you use the wheelchair and have them checked regularly by the specialist dealer.".

Event Description

The client had taken the anti-tippers off of the wheelchair to clean them and forgot to put them back on.She tipped backwards in the garden and fractured her neck.

• Brand Name: KUSCHALL K-ATTRACT
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): KUSCHALL DESIGN AG; benkenstrasse 260; 4108; witterswil ; SZ
• Manufacturer (Section G): KUSCHALL DESIGN AG; benkenstrasse 260; 4108; witterswil ; SZ
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 7201027
• MDR Text Key: 97578198
• Report Number: 9614447-2018-00001
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:DDZ0068
• Device Catalogue Number: DDZ0068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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): Hospitalization
• Patient Weight: 100