MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE 2; MANUAL WHEELCHAIR

Model Number Q2

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

Patient Problem Limb Fracture (4518)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Background information: quickie 2 owner manual (mk-100070, rev.F, page 8) states: "c.Obstacles warning! riding over curbs or obstacles can cause tipping and serious bodily harm.If you have any doubt that you can safely cross any curb or obstacle, always ask for help.Be aware of your riding skills and personal limitations.Develop new skills only with the help of a companion.To avoid the risk of traversing obstacles: keep a lookout for danger - scan the area well ahead of your chair as you ride.Make sure the floor areas where you live and work are level and free of obstructions.Remove or cover threshold strips between rooms.Install a ramp at entry or exit doors.Make sure there is not a drop off at the bottom of the ramp.To help correct your center of balance: lean your upper body forward slightly as you go up over an obstacle.Press your upper body backward as you go down from a higher to a lower level.If your chair has anti-tip tubes, do not go over an obstacle without help.Keep both of your hands on the handrims as you go over an obstacle.Never push or pull on an object (such as furniture or a doorjamb) to propel your chair.If you fail to heed these warnings damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others." discussion: the user's speed is unknown at the time of the incident.This is a manual chair, not equipped by sunrise with a power assist device; therefore, it is presumed that the chair was moving at a normal "rolling" speed for a manual wheelchair.All wheelchairs have an inherent risk of tip over that cannot be removed without lessening the benefit of a wheeled mobility device useful for the disabled population.The benefits of a wheeled mobility device are outweighed by the risk of tip over, as is specific in this case.No higher risk other than that experienced by any manual wheelchair user exists in the current case.Conclusion: sunrise considers this an unfortunate accident, but was not caused by any malfunction of the product and, therefore, considers the matter closed.Should any additional information come to light later, the case may be reopened, if such information warrants follow-up.Additional information: please note that due to technical difficulties, this report will not meet the 30-day initial report requirements.I had to work with webtrader (esg help desk) in order to update my signing certificate which was just cleared today (15-jun-21).

Event Description

Client claimed to be rolling out of a fitness center and hit a crack at the end of the side walk.Stated caster got caught in the crack of the sidewalk causing her to flip out of the chair.Client did suffer a broken ankle and is wearing a cast at the time the dealer saw her about the chair repair on (b)(6) 2021.Other than typical follow-up for a broken foot, no further injuries were reported, nor medical intervention described.Initial report stated that client did not remember if she was in the chair or not when she broke her foot; therefore, directive causation cannot be established.The fall and broken foot with casting warrant this filing for serious injury.

• Brand Name: QUICKIE 2
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328 ; 5592942374
• MDR Report Key: 12005199
• MDR Text Key: 267844383
• Report Number: 9616084-2021-00006
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q2
• Device Catalogue Number: EIQ2X
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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): Other
• Patient Age: 67 YR
• Patient Weight: 75