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

Model Number Q700M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 02/04/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 294032256
• Report Number: 2937137-2022-00003
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: Q700M
• Device Catalogue Number: EIPW25
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 82 KG