MAUDE Adverse Event Report: SUNRISE MEDICAL (US) QUICKIE Q700M; WHEELCHAIR, POWERED

Model Number	Q700M
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Dealer called in and stated end user was leaning on the left side armrest to pull up their pants and the armrest snapped.The end user allegedly fell out of chair onto the floor causing shoulder and neck pain.
Additional Manufacturer Narrative
Background: quickie sedeo ergo seating system seating manual, rev.A (page 8), and quickie q700m owner manual, rev.H (page 11) states: "warning! when transferring to and from the wheelchair, do not use the armrest as a means of support." discussion: in reviewing the complaint, the dealer reports that the user was leaning on the left armrest when it snapped, which led to the user allegedly falling out of the chair onto the ground.The user reports minor injuries (shoulder and neck pain).The possible root cause for the armrest failure is likely due to the user exceeding the load capacity of the armrest.Using the armrests as support are warned against in the quickie q700m owner's manual and the sedeo seating manual.Conclusion: while there is no serious injury (minor injuries were reported), due to previous filings related to similar failure modes, out of an abundance of caution, an mdr is being filed.

• Brand Name: QUICKIE Q700M
• Common Device Name: WHEELCHAIR, POWERED
• 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: 13744418
• Report Number: 2937137-2022-00003
• Device Sequence Number: 11952682
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172384
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: Q700M
• Device Catalogue Number: EIPW25
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 82 KG