MAUDE Adverse Event Report: SUNRISE MEDICAL (US) QUICKIE Q500M; POWER WHEELCHAIR

Model Number Q500M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Fall (1848)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Background information: far (failure analysis report) (b)(4), dated 08/24/2021: "during recent trend monitoring, it was identified that there was an increase in complaints on caster tires coming off the rims starting with june 2021.Initial complaints indicate that they were related to the front casters only." according to far (b)(4), a value added / value engineering project ((b)(4)) had been initiated on september 12, 2021 to address this issue of tire coming off the rim under extreme environmental conditions or aggressive usage.The front caster wheels were revised to add a nylon string to the tire while maintaining the current hardness (82±5 shore a) to ensure a soft ride for the user.For this specific wheelchair at issue in the complaint, the right front caster has previously separated from the right caster hub two separate times and have been replaced.There is no indication that the left front caster was also replaced when the right side was.Discussion: the outside environmental conditions and the temperature during the event were not described.In reviewing the complaint, the user reports the front left caster separated from the hub, allegedly leading to a fall and subsequently minor injuries (bruising and scraping below the knee).The user also alleges that night after the event, he was so upset that he had a seizure and was taken to the hospital.There is no indication that the tire separation or the event caused or contributed to the seizure the patient experienced.Based on the information provided, a potential root cause for the caster tire coming off the rim is the caster tire becoming too soft.A corrective action (vave-71067) has been implemented that would include the addition of nylon strings in the tire design (increasing the caster push force requirement) that would help the tire retain its shape and prevent caster wheels from coming off their hubs under extreme environmental conditions or aggressive usage while continuing to ensure a soft ride for the user.This corrective action is still in progress as of the time of this filing.Conclusion: while there is no serious injury (minor injuries were reported), due to previous filings related to the same failure mode, out of an abundance of caution, an mdr is being filed.The wheelchair involved in this event is being returned to sunrise medical ((b)(4)) for product evaluation.If the evaluation produces additional findings, a supplemental report will be filed.

Event Description

Dealer called in claiming the end user fell out of his chair when the left front caster tire came off the hub while outside on the sidewalk near his home.The patient reports bruising and an area on the left leg below the knee where skin came off.No medical attention was sought for the injury.

• Brand Name: QUICKIE Q500M
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US); 2842 n business park ave; fresno CA 93727
• 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: 13794852
• MDR Text Key: 288869615
• Report Number: 2937137-2022-00004
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 04050063059824
• UDI-Public: (01)04050063059824
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Q500M
• Device Catalogue Number: EIPW30
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2021
• 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 Sex: Male
• Patient Weight: 66 KG