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

Model Number Q500M

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 08/06/2022

Event Type  Injury  

Event Description

Dealer called in claiming the end user's son was helping move the wheelchair at home when the chair abruptly stopped, causing the son to fall and allegedly break his femur.The son was admitted to the hospital for this reported injury.

Manufacturer Narrative

Background information: quickie sedeo pro owner's manual, page 6 states: "this seating system has been set up to match the needs of a particular user.If used by another user, then it may need to be adjusted." quickie q400m/q500m power wheelchair owner's manual, page 7 states: "the overall maximum user weight shall not exceed: standard base - 300 lbs (136 kg) base w/c-me® up to 3mph - 300 lbs (136 kg)".Discussion: in reviewing the complaint, the dealer reports that the end user's son was helping move the wheelchair by driving it.The son sat in the chair and gave it a forward command, leading the chair to move forward, but then the chair abruptly stopped, causing the son to fall out of the chair and allegedly breaking his femur.The son was taken to the hospital and admitted for recovery.No additional details regarding the reported injury and treatment were provided.The root cause for this incident is possibly related to unintended user misuse.The wheelchair was set up and configured to the end user.If another user was to use that chair, it should have been adjusted for the person riding before moving it.There was no mention if the positioning belt was used during the incident.Also, the weight limit for the q500m is 300 lbs.According to the dealer, the end user's son is 300 lbs.The son is at the absolute weight limit of the chair, which in turn could potentially have led to the chair not operating as efficiently.Conclusion: due to the evidence of user malfunction and the serious injury reported (broken femur), out of an abundance of caution, an mdr is being filed.

• Brand Name: QUICKIE Q500M
• Type of Device: POWER 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 ; 5592942374
• MDR Report Key: 15368883
• MDR Text Key: 299356681
• Report Number: 2937137-2022-00011
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 04050063059823
• UDI-Public: (01)04050063059823
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Q500M
• Device Catalogue Number: EIPW30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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): Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 136 KG