MAUDE Adverse Event Report: QUICKIE QM715; POWERED WHEELCHAIR

Model Number	QM715
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discussion: during initial evaluation of this chair, the team determined that the armrests equipped on the subject wheelchair were not designed for weight bearing activities (pressure relief, transfers, etc.) and, therefore, the armrest breakage was not a malfunction in design, manufacture, or assembly of the device.Additional evaluation was performed on 30-sep-2021 and it was discovered, at that time, that the subject wheelchair had actually been equipped with single-post, height-adjustable armrests, not the cantilevered armrests mistakenly believed to be on the subject wheelchair at the time of the initial evaluation.Single-post, height-adjustable armrests are designed for weight bearing activities.Therefore, this was identified as a malfunction and, due to the fall from a power wheelchair, a potential for serious injury was assessed at that time.Therefore, the decision to file an mdr was made at that time.Conclusion: sunrise medical rates falls from power wheelchairs as potential for serious injury.Although the user, in this case, did not suffer a serious injury, due to the possibility for serious injury if the malfunction were to recur, this mdr is being filed.This mdr filing date is based on secondary evaluation performed on 30-sep-2021 and not on the initial evaluation performed within the 30-day period for initial filing.Therefore, this mdr is being filed approximately 4 days later than the due date (based on date of awareness) due to additional information gained after that time period.
Event or Problem Description
Dealer reports that end user fell from chair.Right side armrest broke and may have led to fall.No medical attention was sought for the fall by the end user at the time of the fall.No injury reported.

• Brand Name: QUICKIE QM715
• Common Device Name: POWERED WHEELCHAIR
• MDR Report Key: 12566167
• Report Number: 2937137-2021-00045
• Device Sequence Number: 1140893
• Product Code: ITI
• UDI-Device Identifier: 00016958052367
• UDI-Public: (01)00016958052367
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: QM715
• Device Catalogue Number: EIPW11
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 10/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Weight: 137