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

Model Number KUSCHALL CHAMPION

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in this event was manufactured and sold by invacare (b)(4) and the event occurred in (b)(6).Invacare (b)(4) will conduct the investigation.Invacare is filing this report because the device is also marketed and sold in the u.S.The wheelchair was approx.6 years old at the time of the incident, the expected service life of this product is five years.Invacare is unaware of any previous service to the canes or grips.The push handles and grips have been requested to be returned to invacare (b)(4), to date they have not been returned.Additional information and pictures were received confirming the complaint.The owner¿s manual identifies hand grips as a wear item and their useful life is dependent upon many factors.It also states: ¿once a year, take your wheelchair to a qualified technician for a thorough inspection and servicing.¿ inspect /adjust monthly: inspect back cane hand grips for wear/looseness/deterioration.

Event Description

While in the wheelchair, the end user was being pulled up the stairs.The cane grips slipped off causing her to fall down the stairs.The end user went to the hospital with abrasions of the epidermis, numerous bruises, broken nose, contusions of upper limbs and pain.

Event Description

While in the wheelchair, the end user was being pulled up the stairs.The cane grips slipped off causing her to fall down the stairs.The end user went to the hospital with abrasions of the epidermis, numerous bruises, broken nose, contusions of upper limbs and pain.

Manufacturer Narrative

The wheelchair was returned to invacare europe, an evaluation was completed.It was confirmed that the hand grips could slide from the back canes by applying a horizontal force.The user manual includes instruction for going up and down stairs stating the patient should be moved by two assistants.The first assistant should stand behind the wheelchair holding the push handles.The second assistant should hold a solid part of the front frame to steady the wheelchair from the front.This way, the second assistant could have maintained the wheelchair front frame.Also, the user manual specifies that the assistant should tilt backward the wheelchair before you pull on the push handles.This way, the assistant can't apply a horizontal force on the hand grips.The user manual has a drawing showing how to manage stairs by tilting the wheelchair backward with two assistants, the first behind the chair and the second in front.

• Brand Name: KUSCHALL CHAMPION
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): INVACARE FRANCE OPERATIONS; route de st roch; fondettes
• MDR Report Key: 7766741
• MDR Text Key: 116530223
• Report Number: 8020801-2018-00001
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KUSCHALL CHAMPION
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 59