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

Model Number EIQ2X

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

This mdr filing is to report the injury only.There were no allegations of malfunction or defect made against the wheelchair.The dealer's sole purpose for calling sunrise medical was to report the incident.The dealer advised there was nothing wrong with the chair prior to the incident and there were no damages from the accident.Since there were no allegations of malfunction or defect made against the wheelchair and the incident occurred due to user error, sunrise medical deems this as an isolated and accidental incident.No further investigation will be performed by sunrise medical.

Event Description

Per dealer (b)(6), end user while in the chair, unlocked the wheel locks and rolled down a hill that resulted in him breaking his leg.The dealer stated the end user was unattended at school and care takers did not know he could undo the wheel locks himself.

• Brand Name: QUICKIE 2
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada 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: 9235828
• MDR Text Key: 164165269
• Report Number: 9616084-2019-00011
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2018
• 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; Required Intervention