MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700M; WHEELCHAIR, POWERED

Model Number Q700M

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

Patient Problems Bone Fracture(s) (1870); Head Injury (1879)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

Background: quickie q700m owner's manual, section 2.6, rev h: "safety: using a (vehicle mounted) wheelchair lift wheelchair lifts are used in vans, buses, and buildings to help you move from one level to another.Danger! ensure that the user and all carergivers fully understand the lift manufacturer's instructions for using the passenger lift.Never exceed the lift manufacturer's recommended safe working load and load distribution guidance.Always turn off all power when you are on the lift.If you fail to do so, you may touch the joystick by accident and cause your chair to drive off the platform.Be aware that a roll-stop at the end of the platform may not prevent this.Always position the user securely in the chair to help avoid falls while on the lift.Always ensure the chair is in drive mode when using passenger lift (wheels locked, not in freewheel mode)." discussion: in reviewing the complaint, the dealer reports that the end user was transported into the van by a lift, and after the lift was placed back flush to the ground, she reversed and fell while seated in the wheelchair.The caregiver for the patient reported that the end user allegedly sustained two broken ribs and a head injury during the event.There is no further information on the severity of the head injury.Additional medical appointments and tests are supposed to be conducted at a later date after referrals by the patient's primary caregiver are made, according to the caregiver.There is no report of unintended motion or product malfunction.By all accounts, the wheelchair performed as intended.The individual from the transport company that was assisting the patient into the van should have ensured the chair was turned off and strapped in safely before moving on to the next task.Conclusion: while there is no indication of product malfunction, due to the serious injuries reported (two broken ribs and a head injury), out of an abundance of caution, an mdr is being filed.

Event Description

Dealer reported that the patient was transporting into the van by a lift.When the patient was fully in the van, the driver put the lift back to the ground.The patient decided to reverse and the driver was unable to raise the lift back up fast enough, and that's when the chair fell out of the van.According to the caregiver, the patient allegedly sustained two broken ribs and a head injury.

• Brand Name: QUICKIE Q700M
• 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: 14245987
• MDR Text Key: 290469607
• Report Number: 2937137-2022-00006
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172384
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 127 KG