MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE 7 SERIES; WHEELCHAIR, POWERED

Model Number QM710

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Background information: quickie® qm-710/715hd/720 owner's manual, rev f, page 9 states: "warning! it is dangerous to transfer on your own.It requires good balance and agility.Be aware that there is a point during every transfer when the wheelchair seat is not below you.To prevent a fall: 1.Always turn off power before you transfer to or from your chair.If you fail to do so you may touch the joystick and cause your chair to move when you do not expect it.2.Make sure motor brakes are engaged.This keeps the chair from moving when you transfer.3.Work with your health care professional to learn all safe methods for transfers.· learn how to position your body and how to support yourself during a transfer.· have someone help you until you are sure you can do a safe transfer on your own.4.Move your chair as close as you can to the seat you are transferring to.If possible, use a transfer board.5.Rotate the front casters until they are as far forward as possible.6.Be careful of the footrests.If you can, remove or swing them out of the way.· as a standard rule, never stand on footrests when you transfer.Doing so may damage them or cause your chair to tip.If the footplate is in contact with the ground, it is possible to use the footplate for a transfer.· make sure your feet do not "hang up" or get caught in the space between the footrests.7.Make sure armrests do not interfere.8.Transfer as far back onto the seat surface as you can.This will reduce the risk that you will miss the seat or fall." discussion: in reviewing the complaint, the caregiver reports that the end user fractured her hand while transferring into her wheelchair.The end user was located in the bathroom when the alleged injury occurred.Due to the time frame since the reported incident occurred, the caregiver did not have many additional details on what happened.The caregiver stated that she believed the quickie qm710 was too big for the end user.This could contribute to the incident where if the chair was not properly fitted to the end user's measurements, the user may need to lean or reach in such a way that increases the risk of instability during their transfer.Based on the information available, the most probable root cause is the end user experiencing instability while transferring to her wheelchair.Instructions for safe transfer are included in the wheelchair's owner manual.The end user is currently using one of her previous wheelchairs (quickie freestyle) until she is able to order a new one.The end user sought medical attention from her primary care physician and a hand specialist for the reported hand fracture.She is currently wearing a brace and the hand is healing.According to the caregiver, the doctor stated that the fracture would take around 8 months to fully heal.Conclusion: due to the allegation of a serious injury that requires medical intervention (treatment with a primary care physician and hand specialist), this mdr is being filed.

Event Description

Caregiver reports that the end user allegedly fractured her right hand while transferring into her wheelchair.The end user sought medical attention from her primary care physician and a hand specialist.She is currently wearing a brace and the hand is healing.

• Brand Name: QUICKIE 7 SERIES
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 16022651
• MDR Text Key: 305890116
• Report Number: 2937137-2022-00014
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QM710
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 52 KG