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

Model Number SSP218DDA-ELR

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 08/08/2013

Event Type  malfunction  

Manufacturer Narrative

According to the photos provided by the customer, it is found that the shaft bearing is lost during the usage, causing the front wheel to fall.Check the products in warehouse, lot number ak201309021.It meets the quality requirements of the product.Do the in house test.The test record is ok.Check the drawings.The size is ok.Check the wheelchair assembly work operation manuals.It is ok! check the inspection records of shaft bearing.The record is ok.Check the sales for a few months.There are no similar complaints.(b)(4).

Event Description

Drive medical has received a customer complaint about an incident involving a wheelchair allegedly imported and distributed by drive medical.It is alleged that a nursing home resident was using the wheelchair when the left front wheel came off and caused her to fall.The pt allegedly hit her head on the floor and sustained a 1.5 cm laceration to her left temple.The pt went to the emergency room for eval and did not find any add'l injury.This mdr report is based on the info provided by the customer and pt.

• Brand Name: DRIVE MEDICAL
• Type of Device: SSP218DDA-ELR
• 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: 7394902
• MDR Text Key: 104547604
• Report Number: 3007309323-2018-00003
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Home Health Aide
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 09/06/2013,03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Device Model Number: SSP218DDA-ELR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2013
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/06/2013
• Date Manufacturer Received: 09/07/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2011
• 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): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 64