MAUDE Adverse Event Report: AIKIN HEALTHCARE CO., LT ROLLATOR SFT SEAT BERGUNDY; WALKER, MECHANICAL

Model Number ZCHMT25BG

Device Problems Device Slipped (1584); Device Tipped Over (2589)

Patient Problems Fall (1848); Head Injury (1879); Injury (2348)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

From the device history record, lot number 0916ahoi5243 was shipped on (b)(4) 2016.No exception was recorded in the device history record that could lead to the reported incident.There was no design change at the brake assembly system and materials.At the time of this investigation there was no sample available for investigation, only photos of the sample were provided.However, the photos provided did not show the relevant defect parts.From the investigation, the root cause could not be determined.There is no action taken at this time.

Event Description

Based on information received from the customers daughter, she alleges the following: "cardinal health rollator tipping over, resulting in my elderly mother's slip and fall injury on (b)(6) 2017.Your rollator product had the following failures which resulted in her fall incident: lack of a printed manual instruction with the purchase of the rollator, tipping, and structural failures.The rollator was received through the durable medical equipment distributor (b)(4).Medicare made the purchase and covered the cost of the rollator and it was delivered to our home by (b)(4).The fall incident occurred at a medical building walkway in (b)(6).I was assisting my mother down a slightly inclined walkway in her seated rollator device following a medical visit at the building's clinic.The rollator began to pick up speed, the hand brakes did not work well, and when it hit a crevice the rollator immediately tipped over.Her entire body flipped backwards, and she slammed the back of her head and back (including tailbone, pelvic region) onto the cement pavement.Upon the fall and hearing my scream, two medical staff from the building's clinic came outside, witnessed mom's twisted body on pavement screaming in pain and carried my mother into their clinic where they performed a ct scan for head trauma (dated: (b)(6) 2017).Upon leaving the clinic, she was transferred into a wheelchair and wheeled out of the building.Following the incident, she was taken to an urgent care for further diagnostic tests and evaluation due to the fall's impact on her head and pelvic area (dated: (b)(6) /2017).She was diagnosed with a positive head injury due to the fall".

• Brand Name: ROLLATOR SFT SEAT BERGUNDY
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): AIKIN HEALTHCARE CO., LT; 178 kang zhuang rd.; zhou shi zhen; kunshan jiangsu 21531 4; CH 215314
• Manufacturer (Section G): AIKIN HEALTHCARE CO., LTD; 178 kang zhuang rd.; zhou shi zhen; kunshan jiangsu 21531 4; CH 215314
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9239269
• MDR Text Key: 164253032
• Report Number: 1423537-2019-00366
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: No Information
• Device Model Number: ZCHMT25BG
• Device Catalogue Number: ZCHMT25BG
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other