MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE S636 SC; POWERED WHEELCHAIR

Model Number	EIS62
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After performing a history search for this client, we show that only an (b)(4) sc was purchased.However, since a serial number was not provided in the summons, we are unable to verify that this is the same chair.The summons also does not make mention of any details to the seriousness of the injuries.Nor does it provide any details of the vehicle collision.This mdr is being filed due to the claim that "serious injuries" were involved.However, this will be an ongoing investigation since details of the accident were withheld and the wheelchair was not provided for an evaluation.However, the owner's manual does specifically state on page (9) section (l) warning (1) "never sit in this chair while in a moving vehicle.In an accident or sudden stop you may be thrown from the chair.Wheelchair belts are designed to position the rider only and will not protect you in an accident; further injury may result from the belts." for reporting purposes this mdr is being filed using the serial number for the (b)(4) sc wheelchair, since that is the chair we have on record for the end user.However, if and when we are able to obtain an actual serial number and perform an investigation/evaluation a supplemental mdr will be filed.Per fda medwatch, sunrise medical is filing a 2nd initial mdr 2937137-2016-00020 due to the original mdr, which was submitted on 12/20/2016 could not be located.A supplemental mdr report 2937137-2016-00020-1 was filed and received by fda medwatch on 11/06/2017.
Event or Problem Description
Sunrise medical (us) llc received a court summons on (b)(4) 2016 regarding an incident possibly involving an (b)(4) sc power wheelchair.The summons states that on (b)(6) 2016, end user was a passenger in a custom-made van operated by her father.The end user's chair, which the summons states is an (b)(4) se was secured in the rear of the custom made van which was involved in a motor vehicle collision.It is alleged in the summons that as a result of the collision, the d-ring designed to secure the seatbelt in place failed, causing the end user to become ejected from her chair and suffer serious injuries.
Additional Manufacturer Narrative
A legal notice was received from the law offices of (b)(4) on 10/26/2017 stating that the appointed judge of this case, judge (b)(4), granted the plaintiff's motion to voluntarily dismiss sunrise medical (us) llc from this matter and suit.This case, where a power wheelchair model s636 was involved in a motor vehicle accident; stated that the end user was in the chair while being transported in a van and fell out of the chair when the van collided with another vehicle.The parts that were in question and that failed were installed by complex rehab and were not sunrise medical products.This case is considered closed by sunrise medical.
Event or Problem Description
Intial mdr 2937137-2016-00020.

• Brand Name: QUICKIE S636 SC
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7004827
• Report Number: 2937137-2016-00020
• Device Sequence Number: 3012719
• Product Code: ITI
• UDI-Device Identifier: 05022408044252
• UDI-Public: 05022408044252
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K981462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: EIS62
• Device Catalogue Number: EIS62
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1