MAUDE Adverse Event Report: DOLOMITE BANJO WITH CANE/CRUTCH HOLDER; MECHANICAL WALKER (WHEELS & NO WHEELS)

Model Number EU:1452442

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Rupture (2208)

Event Date 03/02/2018

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 device and additional information about the event have been requested but no further details have been provided at this time.The cause of the issue could not be confirmed without the return of the device.Should additional information become available, a supplemental record will be filed.

Event Description

The right parking brake does not work correctly.The brake was blocked and the brake pad was loose.

Manufacturer Narrative

The device was returned to invacare europe.Their evaluation concluded: the brake system of the affected rollator was investigated, both brake system components were easy to turn in the rear frame tube.The investigation of the wheels showed that the bearings were worn which could lead to a wobbling effect of the rollator.The wobbling of the wheels combined with the turned brake pad, could possibly lead to a continuous small brake effect during movement.As the distance between the brake pad and the wheels is narrowed the force needed to engage the parking brake is higher than the user is accustomed.The most probable cause of the incident is that the parking brake was working but it wasn¿t fully engaged by the user which led to the movement of the rollator on the right site (the left side parking brake was fully engaged) causing the user to fall.

Event Description

The right parking brake does not work correctly.The brake was blocked and the brake pad was loose.

• Brand Name: BANJO WITH CANE/CRUTCH HOLDER
• Type of Device: MECHANICAL WALKER (WHEELS & NO WHEELS)
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio
• MDR Report Key: 7465166
• MDR Text Key: 106634180
• Report Number: 9615290-2018-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EU:1452442
• Device Catalogue Number: 1452442
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR