MAUDE Adverse Event Report: JIANGYIN HUASHI VEHICLE SEAT CO LTD BARIATRIC ROLLATOR 9153651476; WALKER, MECHANICAL

Model Number NA:66550

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

Invacare is reporting this incident in an abundance of caution.The end-user stated that she chose not have the mri her physician requested so a definitive diagnosis is not available.She was unable to provide the serial number/ date code for the 66550 bariatric rollator.Without a date code, the manufacturer of the rollator cannot be determined.This 66550 bariatric rollator is manufactured in (b)(4) by either kenstone or huashi, therefore this medwatch is being filed under invacare (b)(4).Should additional information become available, a supplemental record will be filed.

Event Description

The consumer reported that when she sat on her 66550 bariatric rollator the left front wheel broke, and she fell on the floor.She hurt her left arm, had bruises on her upper thigh and stomach, and complains of having difficulty performing activities for daily living.

Manufacturer Narrative

The 66550 rollator was returned to invacare, where it received an expanded evaluation that was completed on 08/18/2020.The rollator was in a used condition with scratches to the frame, and the wheels had damage, and wear.The front casters, and head-tubes, both showed that they were re-welded to the frame and gussets.The rollator was pushed around, and the wheels rolled and swiveled freely.The left and right brake levers were individually engaged, and each side stopped the wheels from rolling.The complaint was confirmed for both the front head-tubes having been re-welded.The issue of failed welds was previously escalated to the supplier.The following changes were approved and made: the front/rear seat support crossbar weld was changed from manual brazing to robot c02 welding, the front caster positing tube weld was changed from manual brazing to robot c02 welding, the handle tube length was increased to improve handle tube strength.This device was manufactured prior to the implementation of the changes.On the initial medwatch the date code for the product was not know, therefore it was filed under invacare.Upon return, the date code was made available, and the medwatch has been updated with the manufacturers information.

Event Description

The consumer reported that when she sat on her 66550 bariatric rollator the left front wheel broke, and she fell on the floor.She hurt her left arm, had bruises on her upper thigh and stomach, and complains of having difficulty performing activities for daily living.

• Brand Name: BARIATRIC ROLLATOR 9153651476
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI VEHICLE SEAT CO LTD; 218 hualu road; huaxi 1st village; wuxi, jiangsu OH 21442 1; CH 214421
• MDR Report Key: 10038788
• MDR Text Key: 190495731
• Report Number: 1525712-2020-00016
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/27/2020,04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:66550
• Device Catalogue Number: 66550
• Device Lot Number: HI180414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Date Report to Manufacturer: 08/27/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention