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

Model Number QUICKIE Q500M

Device Problems Misassembly by Users (3133); Device Handling Problem (3265)

Patient Problem Bruise/Contusion (1754)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Background information: during investigation into the reported incident, it was discovered that the end user, who lives on the second floor of his residential building, had disassembled the quickie q500 wheelchair and reassembled it on the second floor due to the lack of an elevator in the residential building.It is uncertain at this time who actually disassembled and reassembled the wheelchair, but presumably it was the dealer who actually sold the product to the end user.It is unknown what date the chair was delivered by the dealer to the end user.Discussion: although not cautioned against in the associated quickie q500 owner manual, quickie power wheelchairs come fully assembled from the factory (excluding various accessories).This includes the installation of a seating system on the powered base.These are not meant to, nor intended to be disassembled outside of the factory setting.Since the entity that disassembled the wheelchair was not a sunrise medical manufacturing specialist, this is considered user tampering.The most likely cause of the incident was due to a misassembly issue by an untrained person or persons in an effort to transport the q500 power chair to the second floor of the end user's residential building more easily.It is unknown what tools were used or what level of competence the person had.Ongoing investigation is being performed in this case in order to determine the exact mechanism of failure (root cause investigation) as we are waiting for the return of the affected product to sunrise medical for full investigation.Upon receipt of the product, a failure analysis report will be generated and, at that time, if further information leads to a specific cause of the failure, a supplemental report will be filed.Conclusion: the cause of the incident is currently identified as user tampering.

Event Description

On (b)(6) 2021, the end user was using his quickie q500 midwheel drive wheelchair in his home in a reclined position when the backrest collapsed.The end user fell out of the wheelchair and the wheelchair tipped over on top of the end user.Due to his disability, he was unable to extricate himself from under the wheelchair and called an ambulance service to assist him.He was pinned under the chair, on the floor, for approximately 4 hours.After being extricated by the emergency services personnel, he was transported to the hospital where medical evaluation that the end user had not suffered any injuries other than some mild bruising.No medical treatment was provided and no future medical care was ordered.Due to this incident, this report is being filed out of an abundance of caution due to a potential malfunction in the case of the wheelchair.

Event Description

During the time of the initial report, it was believed that the user disassembling and reassembling the wheelchair (user misuse) is what led to the failure of this device.However, additional information has determined that this was not the cause of the malfunction of the device.Failure analysis report (far 40011) dated 25-may-2021 discusses that the anti-shear subassembly (part number 22503000-002) fractured and broke off of the left slide rail in the power recline assembly of the wheelchair.This fracture as most likely caused by the plastic material not being made to specification.Further analysis and proposal for corrective actions have been undertaken with the supplier.In addition, it is possible that incorrect assembly of the sliding bearing (pn 21803311) may also have been a factor in this malfunction.However, laboratory testing could not replicate the failure, therefore, assembly processes have been discarded as a root cause.Follow-up has ensued with the supplier of the part.If new information is received in the future, supplemental report will be filed.

Manufacturer Narrative

Background information: the quickie sedeo pro seating manual (248020 rev d) routine maintenance instructions call for weekly check of the frame and base for "foreign objects and/or obstructions." discussion: additional investigation was conducted as a result of retrospective review of filings.During the investigation documented in far-40011 it was identified that the plastic slide bearing bushing cracked leading to metal-on-metal contact between the slide bearing and the slide rail.Damage to the slide rail was consistent with fatigue damage that eventually led to an inability of the slide mechanism to operate, resulting in the actuator pulling the slide plate off the rails.On the returned backrest some evidence of interference damage of indeterminant origin was noted on the control lever assembly.Testing was performed to attempt to replicate the failure because of the improper slide bearing assembly.The failure could not be replicated (trq-00949), so contribution from incorrect assembly was eliminated as a cause.No material changes or supplier nonconformities were identified that could have contributed to the failure; as such, the supplier was eliminated as a root cause for this failure.Testing was performed on a simulated case where an external obstruction was introduced to the assembly and the failure was replicated.Conclusion: evaluation and testing of the returned product indicates that the most probable cause is user error.It was determined that an external object became entrapped in the anti-shear mechanism leading to product failure.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.This is most likely not a malfunction and is not likely to result in serious injury or death if it were to recur.

Event Description

The end user was using his quickie q500 midwheel drive wheelchair in a reclined position when the backrest collapsed causing him to fall from the wheelchair and the chair to then fall on top of him.Due to his disability, he was unable to extricate himself from underneath the wheelchair and called an ambulance service to assist him.He was pinned under the chair for approximately 4 hours.After being extricated by the emergency services personnel, he was transported to the hospital for medical evaluation.It was determined that the end user had not suffered any major injuries, only some mild bruising.No future medical care was ordered.

• Brand Name: QUICKIE
• Type of Device: POWERED, WHEELCHAIR
• 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 93727-1328 ; 5592942374
• MDR Report Key: 11630969
• MDR Text Key: 247925222
• Report Number: 9616084-2021-00003
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE Q500M
• Device Catalogue Number: EIPW30
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 125 KG