MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD DRIVE; SSP218DDA-SF

Model Number SSP218DDA-SF

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

We were be informed one mdr from customer in (b)(6) 2016.The medical device involved in the incident is a wheelchair, item #ssp218dda-sf with serial number (b)(4).We checked same item in warehouse.(see attachment 1 record).According to description, the end user was trying to get out of the bed and into the wheelchair, her legs extended over the arms of the wheelchair.But her leg got caught by the armrest pushbutton.The role of the armrest pushbutton is to prevent the armrest from falling off and disassembling.From the bed to the wheelchair, the armrest should be removed firstly, then after moving, the armrest should be finally mounted.But when the end user from the bed to the wheelchair, the armrest was not removed firstly.We think the user is not used properly.According to serial number (b)(4), the po number is (b)(4), lot number is ak2015060090.There are totally 22pcs ssp218dda-sf.The armrest pushbutton inspection record is ok.We checked the sales record of this product nearly three months, no similar complaints in the last three months, this user complaint is an anomaly.

Event Description

Drive medical received a noticed of incident which involves the wheelchair that drive medical imports and distributes.Th patient was seen by the caregiver sitting on the edge of the bed with her legs extended over the arms of the wheelchair.Allegedly, the patient was trying to get out of the bed and into the wheelchair when her leg got caught by the armrest pushbutton.The back of her leg was allegedly cut, and she lost a lot of blood.No product defect or other problems in the wheelchair has been reported to drive medical.This report is based on the information from the caregiver who is also the daughter of the patient.

• Brand Name: DRIVE
• Type of Device: SSP218DDA-SF
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD; no 297, chuqiao road; zhenjiang, 21200 9; CH 212009
• Manufacturer (Section G): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD; no 297, chuqiao road; zhenjiang, jiangsu 21200 9; CH 212009
• Manufacturer Contact: ying mei ; no 297, chuqiao road; zhenjiang, jiangsu 21200-9 ; CH 212009
• MDR Report Key: 7372441
• MDR Text Key: 103530158
• Report Number: 3007309323-2018-00001
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• PMA/PMN Number: K112816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 04/08/2016,03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Device Model Number: SSP218DDA-SF
• Device Lot Number: AK2015060090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2016
• Distributor Facility Aware Date: 04/08/2016
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 04/08/2016
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 66