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

Model Number	EIPW11
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical's customer service supervisor, (b)(6) called and spoke with the end user's husband.He explained that his wife stood up and moved forward away from the chair to put money in the laundry machine and the footplates dropped from the up position to the down position.His wife was unable to bend over far enough to put the plates back up so she attempted to back up, step over the plates and sit down in the chair at the same time.However she was not able to reach the seat, missed it and fell down.She was taken to (b)(6) hospital and was there for 5 days for contusions to her back, buttocks, right knee and back of head.She was then taken to warm springs rehab for 7 days of physical therapy.End call.This mdr is to report the injury only.There were no allegations of malfunction or defect made against the subject wheelchair that may have caused or contributed to the incident.There was no request for replacement parts since no items failed on the chair.The end user is in contact with her dealer (b)(6) for any further assistance she may require.Sunrise medical deems this an accidental incident and no further investigation will be performed at this time.
Event or Problem Description
Dealer, (b)(6), reported that the end user was at a laundromat about a month ago and stood up from the chair to put money in the laundry machine.When she went to sit back down, she fell.(b)(6) stated the end user was taken to the hospital and stayed there for 5 days, then was taken to a rehab facility.The length of time there and services are unknown.

• 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: 8430838
• Report Number: 2937137-2019-00010
• Device Sequence Number: 2594089
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/05/2019

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
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/18/2019
• 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: 56 YR
• Patient Weight: 94