MAUDE Adverse Event Report: MAXHEALTH CORP. ROSCOE E-SERIES ROLLATOR

Model Number 30166

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problems Fall (1848); Head Injury (1879); Brain Injury (2219)

Event Date 06/20/2016

Event Type  Death  

Event Description

The consumer fell from the rollator onto the concrete sidewalk, and sustained severe injuries to her head and to her brain.The consumer was of advanced age, and was not feeling well at the time, so she was sitting on the rollator as her daughter pushed it, in order to enter the building from the parking lot.It was necessary to push the consumer up a concrete wheelchair ramp located in the parking lot to the sidewalk.At the top of the ramp, and at the point where the ramp met the concrete sidewalk, the elevation of the ramp was not level with the elevation of the sidewalk - this point of transition had been constructed and/or maintained such that there was an abrupt elevation change and hazard where the ramp met the sidewalk.As the consumer was pushed up the ramp, and when the rollator reached the transition point where the ramp met the sidewalk, the wheels of the rollator came into contact with the hazardous elevation change, causing the rollator to suddenly and unexpectedly stop and pitch over.The consumer fell from the rollator onto the concrete sidewalk and sustained injuries to her head and to her brain.This event was considered misuse of the rollator, as the device's hang tag (user manual) states, under safety precautions, "do not use your rollator as a wheelchair.Do not use on rough or uneven surfaces.Doing so may cause it to tip-over, resulting injury.Never use stairs or escalators while using the rollator.Do not use on inclines over 80%.".

Event Description

Update to patient outcome: compass health brands was made aware of death on (b)(6) 2017, via attorney, but quality department/regulatory that files the reports with fda was only made aware of "serious injuries" until 07/01/2019.Customer service error in documenting complaint.

• Brand Name: ROSCOE E-SERIES ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, taiwan 221 ; TW 221
• MDR Report Key: 6364279
• MDR Text Key: 68501181
• Report Number: 3012316249-2017-00019
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 30166
• Device Catalogue Number: 30166
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Distributor Facility Aware Date: 02/03/2017
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other