MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES QUICKIE 2; MANUAL WHEELCHAIR

Model Number EIQ2X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Sunrise medical's legal department received on 3/28/2018 additional information and update from the plaintiff's legal counsel stating that the plaintiff had the wheelchair in question for approximately 6 months before the incident.The plaintiff alleged that he "was having a problem with the rear wheels" and that the chair was sent to a local dealer/repair shop named (b)(6) for repairs.The plaintiff claimed that "he was going forward, the wheels locked, the chair tipped over and threw him forward onto the sidewalk." it was alleged that he sustained a fractured right shoulder and is still hospitalized at the va hospital.The plaintiff's counsel provided two photos of the wheelchair.It was determined by sunrise medical's ra/qa department, after reviewing the photos that the plaintiff's wheelchair was a quickie 2 manual wheelchair manufactured by sunrise medical.The photos also revealed that the chair had been modified and equipped with an e-fix device.This device is a type of power assist/motorized wheel that can be controlled with a joystick.The e-fix device is not a sunrise medical product.The wheelchair's serial (b)(4) was also provided by the plaintiff's counsel.This chair was purchased on (b)(6) 2017 by the veteran's association in (b)(6) and drop shipped to (b)(6).After reviewing the specifications of chair (b)(4), it was shown that it was manufactured and left our facility with standard, non-motorized rear wheels.The chair was modified with the e-fix, after-market device at some time after the user took delivery of the quickie 2 manual wheelchair.The plaintiff alleges that the e-fix device is what caused the fall and subsequent injury.There were no allegations of malfunction or defect made against the quickie 2 wheelchair.No further investigation will be performed.

Event Description

On (b)(6) 2018 sunrise medical received via united states postal service an injury claim letter issued by the law offices of (b)(6).The notice states in paragraph 2, "(plaintiff) was seriously injured as a result of being thrown from his wheelchair outside his apartment complex on (b)(6) 2018.We are investigating all potential causes of the incident, including any defects or malfunctions of the quickie wheelchair with attached e-fix device.".

• Brand Name: QUICKIE 2
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 7445271
• MDR Text Key: 106006526
• Report Number: 9616084-2018-00004
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIQ2X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization