MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD DRIVE; CX418ADDA-SF

Model Number CX418ADDA-SF

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

We are be informed one mdr from customer in (b)(6) 2016.The medical device involved in the incident is a?cruiser x4 wheelchair, item: cx418adda-sf.Serial number (b)(4)according to the description and survey, the end user was attempting to move from the bed to the wheelchair, the hight adjustable armrest was not locked, so the armrest fell off, causing the patient to fall.We checked the manual of cruiser x4 chair and found it doesn't have usage instruction for hight adjustable armrest.We sent the test report to customer.According to serial number (b)(4), we checked the po number (b)(4) and lot no.Ak2015110083, there are totally 10pcs cx418adda-sf in this order.And we also checked the three batches before this order.We checked the sales records, no similar complaints.We communicate with customer to do some survey, from the pictures they offered, we cannot find any defects.The sales people told customer about the improvements of manual, add any usage instruction for hight adjustable armrest.The customer agree with the solution.

Event Description

Drive devilbiss healthcare was notified by a claims representative of an incident involving a wheelchair that is imported and distributed by drive.The end user was attempting to move from the bed to the wheelchair when the arm rest fell off, causing the patient to fall and fracture his femur.The patient underwent surgery and was hospitalized for 4 days.

• Brand Name: DRIVE
• Type of Device: CX418ADDA-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: 7372444
• MDR Text Key: 103568524
• Report Number: 3007309323-2018-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 03/15/2018,12/03/2018

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: Lay User/Patient
• Device Model Number: CX418ADDA-SF
• Device Lot Number: AK2015110083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Distributor Facility Aware Date: 11/28/2016
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 12/28/2016
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization