MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM715; POWERED WHEELCHAIR

Model Number QM715

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 08/26/2021

Event Type  malfunction  

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 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
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• MDR Report Key: 12566167
• MDR Text Key: 274512235
• Report Number: 2937137-2021-00045
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958052367
• UDI-Public: (01)00016958052367
• Combination Product (y/n): N
• PMA/PMN Number: K060531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QM715
• Device Catalogue Number: EIPW11
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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 Weight: 137