MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR

Model Number	EIPW11
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(6), he also states that this isn't the first time his client has flipped a chair.She has done this in a different non-quickie brand wheelchair.The end user has not used her current chair since the accident.The dealer states the incline where the incident occurred isn't too steep.It's an incline on the sidewalk located at the apartments where the end user lives.By incline, the dealer is referring to the slope on the sidewalk where pedestrians walk up onto and down off of the sidewalk.The qm7-series owner's manual states on page 10, section s.To reduce the risk of a fall, tip-over or loss of control, point 1.Never use your chair on a slope unless you are sure you can do so without losing traction.Point 2.Always go as straight up and as straight down as you can.Do not "cut the corner" on a slope or ramp.Do not turn or change direction on a slope.Point 4.Keep your chair moving at a slow, steady speed.Keep control over the chair at all times.On a descent, do not let your chair accelerate beyond its normal speed.Upon reviewing the complaint and based on what the dealer has stated, sunrise medical has determined that it is likely the chair tipped over due to the end user not adhering to the instructions/warnings as listed above in the owner's manual.There were no allegations of malfunction or defect made against the subject wheelchair.No further investigation will be performed by sunrise medical.
Event or Problem Description
On (b)(6) 2018 dealer (b)(6) called sunrise medical to report that the client flipped her chair over onto the right side.Per (b)(6), the client stated, "she was coming down an incline and turning right then to the left and then spun all the way around to the right and tipped over".(b)(6) says the client flipped her chair on (b)(6) 2018 and received medical attention same day at (b)(6) hospital.Per (b)(6), the client allegedly suffered a cracked rib.

• Brand Name: QUICKIE QM710
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7976404
• Report Number: 2937137-2018-00013
• Device Sequence Number: 1421278
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 89