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

Model Number EIZ4-2

Device Problem Device Tipped Over (2589)

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

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018 dealer (b)(6) stated that the mother was pushing her daughter in the chair when the incident occurred.Her daughter actually cannot self-propel.(b)(6) stated that they live in a rural area in (b)(6) and when they came across a gravel area, the smaller wheels on the front got caught in the gravel causing the chair to tip forward.The end user did have her lap belt on at the time.The chair did tip over forward completely landing on top of the end user and she broke her leg.It is stated on page 6, section j: terrain of the quickie iris owner's manual the following: point 2: your chair is designed for use on firm, even surfaces such as concrete, asphalt, indoor flooring and carpets.Point 3: do not operate your chair in sand, loose soil, or over rocky terrain.Page 7, section c: obstacles of the owner's manual states the following: riding over curbs or obstacles can cause tipping and serious bodily harm.Per (b)(6) , the end user was treated for the broken leg and he is now looking into possibly making some adjustments to improve the center of gravity and maybe adding larger front wheels.There were no allegations of malfunction or defect made against the subject wheelchair.No further investigation will be performed by sunrise medical.

Event Description

On (b)(6) 2018 dealer (b)(6) stated the user was propelling outside and propelled over some gravel and the chair tipped over and fell out of the chair.Broke her leg and did seek medical attention.

• Brand Name: QUICKIE IRIS
• 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: 7976201
• MDR Text Key: 124071778
• Report Number: 9616084-2018-00010
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 05022408048953
• UDI-Public: 05022408048953
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIZ4-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2014
• 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
• Patient Age: 24 YR
• Patient Weight: 50